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U.S. allows pharmacists to prescribe Paxlovid directly
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
When too much treatment creates more harm than good
Ann Marco, 73, who was diagnosed with ovarian cancer in late 2018, credits her oncology team for saving her life. They treated her with chemotherapy, debulking surgery, and more chemotherapy. But it is her second and current care team that helped restore Ms. Marco’s quality of life, directing her toward such resources as palliative care, physical therapy and counseling for her and her husband.
“I can’t say enough about my palliative care doctor. She helped me manage pain, and the fatigue associated with chemotherapy. When she noticed that my leg was swollen she suspected a blood clot and sent me for an ultrasound,” Ms. Marco said.
The ultrasound revealed that she did indeed have a blood clot, for which she received, and continues to receive, medication. “Because with ovarian cancer, you always have blood clots. So little things like that, though they’re not that little, have really helped me in my journey with this cancer,” Ms. Marco said.
That journey has had its ups and downs. One chemotherapy regimen was so intolerable she decided to discontinue it, with full support of her oncologist. I told her, I just want to live my life, whether that’s only 6 more months or 3 years, but I don’t want to live it like this. And she said, ‘Ann, we’re going to do what you want to do.’”
Nine months later, when her cancer started growing again, Ms. Marco returned to chemotherapy. But this regimen has been much more tolerable, and it also appears to be doing its job. A recent CT scan showed that the tumors are shrinking.
“They’ll never go away. I have metastatic cancer. But they’re smaller, and I was really thrilled about that. It’s the best news I’ve had in more than 3 years,” Ms. Marco said.
End-of-life aggressive care still common
, shows a study published in JCO Oncology Practice.
“We have good evidence that the types of aggressive end-of-life care we looked at in this paper are generally related to a lower quality of life for patients, poorer bereavement outcomes for their families, and even shorter duration survivals,” said lead author Megan A. Mullins, PhD, MPH, a postdoctoral research fellow at the University of Michigan in Ann Arbor. “This suggests there’s a disconnect between what people think aggressive care might do and what it’s doing.”
In their evaluation of variation in end-of-life care, Dr. Mullins and her colleagues analyzed SEER-Medicare data on 6,288 women with ovarian cancer who died between 2016 and 2020. They found that 51% of those women received some form of aggressive cancer care. The most common forms were not being admitted to hospice (28.9%), receiving an invasive procedure (20.7%) and being admitted to an intensive care unit (18.6%).
Dr. Mullins noted that since palliative care was officially recognized as a specialty in 2006, there has been increasing guidance for earlier integration of palliative care and reducing the aggressiveness of end-of-life care; both ASCO and the National Quality Form have standards advising against aggressive end-of-life care.
“But there are a lot of complicated factors that I think make it hard to move the needle in this area,” she said. “For one thing, particularly with ovarian cancer, women tend to have recurrences. I’ve spoken with physicians who got their patients through a difficult patch; they rebounded and they did fine. You don’t know for sure if that’s going to happen again if you try something else. Prognostication is not an exact science.”
Also, end-of-life discussions can be challenging conversations. “Nobody wants to take hope away from their patients. But there’s evidence to show that these conversations don’t actually reduce patients’ hopes – that’s a misconception,” Dr. Mullins said.
“It’s challenging. In the United States, we don’t like to talk about death and dying. But I think having these conversations earlier and more often can help make them a more regular part of care,” she said.
Brittany A. Davidson, MD, a gynecologic oncologist with Duke Health in Durham, N.C., who wrote an accompanying editorial, acknowledges that end-of-life can be fraught with fear, anxiety, and a lot of emotion. But she finds helping patients and their families navigate the ups and downs of their cancer one of the most rewarding aspects of her career as a physician.
“We want to help patients and their family members make these transitions as smoothly as possible,” she said.
A proponent of communications skills training for physicians in general, Dr. Brittany said doctors can learn to identify cues that patients are ready to have conversations about their end-of-life care.
“Those cues will help us facilitate conversations sooner rather than later so we’re not waiting until the very end,” she said.
What these conversations consist of varies depending on where the patient is in her cancer trajectory. In a patient with recurrent ovarian or recurrent uterine cancer, this might start with making sure the patient understands that while their cancer is treatable, it is very unlikely to be curable.
“I have often had patients who have been treated for cancer for several years and didn’t know their cancer wasn’t curable. How many missed opportunities have we overlooked?” Dr. Davidson said.
Then the conversation can turn to the goals of treatment. What’s important to the patient? “Are there events they want to be around for? Symptoms they want to avoid? Some patients really want to know what it’s going to be like to die. I try to take the lead from the patient. Ask what kind of information is helpful to them. Is it numbers? Is it symptoms? It’s really different for everybody,” Dr. Davidson said.
Although Dr. Mullins’s research and Dr. Davidson’s editorial suggest there’s room for improvement toward achieving goal-concordant care in gynecological cancers, Dr. Davidson suspects these patients might be faring a bit better than patients with other types of cancer based on her own anecdotal observations.
“One of the unique things about gynecologic oncology is that we have an amazing longitudinal relationship with our patients – we are not only their surgeons, we’re their oncologists. In other solid tumors, care is fractionated.
“That’s one of the reasons I love gynecologic oncology. I have the opportunity to know my patients through all the stages they experience as part of their cancer. I’d like to think that allows me a better opportunity to get to know them and help them recognize the value of palliative care,” Dr. Mullins said.
Ann Marco, 73, who was diagnosed with ovarian cancer in late 2018, credits her oncology team for saving her life. They treated her with chemotherapy, debulking surgery, and more chemotherapy. But it is her second and current care team that helped restore Ms. Marco’s quality of life, directing her toward such resources as palliative care, physical therapy and counseling for her and her husband.
“I can’t say enough about my palliative care doctor. She helped me manage pain, and the fatigue associated with chemotherapy. When she noticed that my leg was swollen she suspected a blood clot and sent me for an ultrasound,” Ms. Marco said.
The ultrasound revealed that she did indeed have a blood clot, for which she received, and continues to receive, medication. “Because with ovarian cancer, you always have blood clots. So little things like that, though they’re not that little, have really helped me in my journey with this cancer,” Ms. Marco said.
That journey has had its ups and downs. One chemotherapy regimen was so intolerable she decided to discontinue it, with full support of her oncologist. I told her, I just want to live my life, whether that’s only 6 more months or 3 years, but I don’t want to live it like this. And she said, ‘Ann, we’re going to do what you want to do.’”
Nine months later, when her cancer started growing again, Ms. Marco returned to chemotherapy. But this regimen has been much more tolerable, and it also appears to be doing its job. A recent CT scan showed that the tumors are shrinking.
“They’ll never go away. I have metastatic cancer. But they’re smaller, and I was really thrilled about that. It’s the best news I’ve had in more than 3 years,” Ms. Marco said.
End-of-life aggressive care still common
, shows a study published in JCO Oncology Practice.
“We have good evidence that the types of aggressive end-of-life care we looked at in this paper are generally related to a lower quality of life for patients, poorer bereavement outcomes for their families, and even shorter duration survivals,” said lead author Megan A. Mullins, PhD, MPH, a postdoctoral research fellow at the University of Michigan in Ann Arbor. “This suggests there’s a disconnect between what people think aggressive care might do and what it’s doing.”
In their evaluation of variation in end-of-life care, Dr. Mullins and her colleagues analyzed SEER-Medicare data on 6,288 women with ovarian cancer who died between 2016 and 2020. They found that 51% of those women received some form of aggressive cancer care. The most common forms were not being admitted to hospice (28.9%), receiving an invasive procedure (20.7%) and being admitted to an intensive care unit (18.6%).
Dr. Mullins noted that since palliative care was officially recognized as a specialty in 2006, there has been increasing guidance for earlier integration of palliative care and reducing the aggressiveness of end-of-life care; both ASCO and the National Quality Form have standards advising against aggressive end-of-life care.
“But there are a lot of complicated factors that I think make it hard to move the needle in this area,” she said. “For one thing, particularly with ovarian cancer, women tend to have recurrences. I’ve spoken with physicians who got their patients through a difficult patch; they rebounded and they did fine. You don’t know for sure if that’s going to happen again if you try something else. Prognostication is not an exact science.”
Also, end-of-life discussions can be challenging conversations. “Nobody wants to take hope away from their patients. But there’s evidence to show that these conversations don’t actually reduce patients’ hopes – that’s a misconception,” Dr. Mullins said.
“It’s challenging. In the United States, we don’t like to talk about death and dying. But I think having these conversations earlier and more often can help make them a more regular part of care,” she said.
Brittany A. Davidson, MD, a gynecologic oncologist with Duke Health in Durham, N.C., who wrote an accompanying editorial, acknowledges that end-of-life can be fraught with fear, anxiety, and a lot of emotion. But she finds helping patients and their families navigate the ups and downs of their cancer one of the most rewarding aspects of her career as a physician.
“We want to help patients and their family members make these transitions as smoothly as possible,” she said.
A proponent of communications skills training for physicians in general, Dr. Brittany said doctors can learn to identify cues that patients are ready to have conversations about their end-of-life care.
“Those cues will help us facilitate conversations sooner rather than later so we’re not waiting until the very end,” she said.
What these conversations consist of varies depending on where the patient is in her cancer trajectory. In a patient with recurrent ovarian or recurrent uterine cancer, this might start with making sure the patient understands that while their cancer is treatable, it is very unlikely to be curable.
“I have often had patients who have been treated for cancer for several years and didn’t know their cancer wasn’t curable. How many missed opportunities have we overlooked?” Dr. Davidson said.
Then the conversation can turn to the goals of treatment. What’s important to the patient? “Are there events they want to be around for? Symptoms they want to avoid? Some patients really want to know what it’s going to be like to die. I try to take the lead from the patient. Ask what kind of information is helpful to them. Is it numbers? Is it symptoms? It’s really different for everybody,” Dr. Davidson said.
Although Dr. Mullins’s research and Dr. Davidson’s editorial suggest there’s room for improvement toward achieving goal-concordant care in gynecological cancers, Dr. Davidson suspects these patients might be faring a bit better than patients with other types of cancer based on her own anecdotal observations.
“One of the unique things about gynecologic oncology is that we have an amazing longitudinal relationship with our patients – we are not only their surgeons, we’re their oncologists. In other solid tumors, care is fractionated.
“That’s one of the reasons I love gynecologic oncology. I have the opportunity to know my patients through all the stages they experience as part of their cancer. I’d like to think that allows me a better opportunity to get to know them and help them recognize the value of palliative care,” Dr. Mullins said.
Ann Marco, 73, who was diagnosed with ovarian cancer in late 2018, credits her oncology team for saving her life. They treated her with chemotherapy, debulking surgery, and more chemotherapy. But it is her second and current care team that helped restore Ms. Marco’s quality of life, directing her toward such resources as palliative care, physical therapy and counseling for her and her husband.
“I can’t say enough about my palliative care doctor. She helped me manage pain, and the fatigue associated with chemotherapy. When she noticed that my leg was swollen she suspected a blood clot and sent me for an ultrasound,” Ms. Marco said.
The ultrasound revealed that she did indeed have a blood clot, for which she received, and continues to receive, medication. “Because with ovarian cancer, you always have blood clots. So little things like that, though they’re not that little, have really helped me in my journey with this cancer,” Ms. Marco said.
That journey has had its ups and downs. One chemotherapy regimen was so intolerable she decided to discontinue it, with full support of her oncologist. I told her, I just want to live my life, whether that’s only 6 more months or 3 years, but I don’t want to live it like this. And she said, ‘Ann, we’re going to do what you want to do.’”
Nine months later, when her cancer started growing again, Ms. Marco returned to chemotherapy. But this regimen has been much more tolerable, and it also appears to be doing its job. A recent CT scan showed that the tumors are shrinking.
“They’ll never go away. I have metastatic cancer. But they’re smaller, and I was really thrilled about that. It’s the best news I’ve had in more than 3 years,” Ms. Marco said.
End-of-life aggressive care still common
, shows a study published in JCO Oncology Practice.
“We have good evidence that the types of aggressive end-of-life care we looked at in this paper are generally related to a lower quality of life for patients, poorer bereavement outcomes for their families, and even shorter duration survivals,” said lead author Megan A. Mullins, PhD, MPH, a postdoctoral research fellow at the University of Michigan in Ann Arbor. “This suggests there’s a disconnect between what people think aggressive care might do and what it’s doing.”
In their evaluation of variation in end-of-life care, Dr. Mullins and her colleagues analyzed SEER-Medicare data on 6,288 women with ovarian cancer who died between 2016 and 2020. They found that 51% of those women received some form of aggressive cancer care. The most common forms were not being admitted to hospice (28.9%), receiving an invasive procedure (20.7%) and being admitted to an intensive care unit (18.6%).
Dr. Mullins noted that since palliative care was officially recognized as a specialty in 2006, there has been increasing guidance for earlier integration of palliative care and reducing the aggressiveness of end-of-life care; both ASCO and the National Quality Form have standards advising against aggressive end-of-life care.
“But there are a lot of complicated factors that I think make it hard to move the needle in this area,” she said. “For one thing, particularly with ovarian cancer, women tend to have recurrences. I’ve spoken with physicians who got their patients through a difficult patch; they rebounded and they did fine. You don’t know for sure if that’s going to happen again if you try something else. Prognostication is not an exact science.”
Also, end-of-life discussions can be challenging conversations. “Nobody wants to take hope away from their patients. But there’s evidence to show that these conversations don’t actually reduce patients’ hopes – that’s a misconception,” Dr. Mullins said.
“It’s challenging. In the United States, we don’t like to talk about death and dying. But I think having these conversations earlier and more often can help make them a more regular part of care,” she said.
Brittany A. Davidson, MD, a gynecologic oncologist with Duke Health in Durham, N.C., who wrote an accompanying editorial, acknowledges that end-of-life can be fraught with fear, anxiety, and a lot of emotion. But she finds helping patients and their families navigate the ups and downs of their cancer one of the most rewarding aspects of her career as a physician.
“We want to help patients and their family members make these transitions as smoothly as possible,” she said.
A proponent of communications skills training for physicians in general, Dr. Brittany said doctors can learn to identify cues that patients are ready to have conversations about their end-of-life care.
“Those cues will help us facilitate conversations sooner rather than later so we’re not waiting until the very end,” she said.
What these conversations consist of varies depending on where the patient is in her cancer trajectory. In a patient with recurrent ovarian or recurrent uterine cancer, this might start with making sure the patient understands that while their cancer is treatable, it is very unlikely to be curable.
“I have often had patients who have been treated for cancer for several years and didn’t know their cancer wasn’t curable. How many missed opportunities have we overlooked?” Dr. Davidson said.
Then the conversation can turn to the goals of treatment. What’s important to the patient? “Are there events they want to be around for? Symptoms they want to avoid? Some patients really want to know what it’s going to be like to die. I try to take the lead from the patient. Ask what kind of information is helpful to them. Is it numbers? Is it symptoms? It’s really different for everybody,” Dr. Davidson said.
Although Dr. Mullins’s research and Dr. Davidson’s editorial suggest there’s room for improvement toward achieving goal-concordant care in gynecological cancers, Dr. Davidson suspects these patients might be faring a bit better than patients with other types of cancer based on her own anecdotal observations.
“One of the unique things about gynecologic oncology is that we have an amazing longitudinal relationship with our patients – we are not only their surgeons, we’re their oncologists. In other solid tumors, care is fractionated.
“That’s one of the reasons I love gynecologic oncology. I have the opportunity to know my patients through all the stages they experience as part of their cancer. I’d like to think that allows me a better opportunity to get to know them and help them recognize the value of palliative care,” Dr. Mullins said.
How to manage cancer pain when patients misuse opioids
Opioids remain a staple in pain management for cancer, but there is little guidance around how to treat patients who have a history of opioid misuse.
Recently,
“There is a tendency to ignore treatment of opioid use disorder in advanced cancer patients because people think: ‘Oh, this person has bigger fish to fry,’ but that’s not a very patient-centric way of looking at things,” senior author Jessica Merlin, MD, PhD, with the University of Pittsburgh, said in a news release.
“We know that opioid use disorder is a really important factor in quality of life, so addressing opioid addiction and prescription opioid misuse in people with advanced cancer is really critical,” Dr. Merlin added.
The study was published online in JAMA Oncology.
To improve care for people with advanced cancer and cancer-related pain, the researchers first assessed how clinicians currently treat patients with opioid complexity.
Using an online Delphi platform, the team invited 120 clinicians with expertise in palliative care, pain management, and addiction medicine to weigh in on three common clinical scenarios – a patient with a recent history of untreated opioid use disorder, a patient taking more opioids than prescribed, and a patient using nonprescribed benzodiazepines.
For a patient with cancer and a recent history of untreated opioid use disorder, regardless of prognosis, the panel deemed it appropriate to begin treatment with buprenorphine/naloxone for pain but inappropriate to refer the patient to a methadone clinic. The panel felt that going to a methadone clinic would be too burdensome for a patient with advanced cancer and not possible for those with limited prognoses.
“This underscores the importance of access to [opioid use disorder] treatment in cancer treatment settings, including non–addiction specialists waivered to prescribe buprenorphine/naloxone and addiction specialists for more complex cases,” the authors wrote.
For a patient with untreated opioid use disorder, the panel deemed split-dose methadone (two to three times daily) appropriate in those with limited prognosis of weeks to months but was uncertain about the suitability of this approach for patients with longer prognoses of a year or longer.
The appropriateness of initiating treatment with a full-agonist opioid was considered uncertain for a patient with limited prognosis and inappropriate for a patient with longer prognosis.
For a patient with cancer pain and no medical history of opioid use disorder but taking more opioids than prescribed, regardless of prognosis, the panel felt it was appropriate to increase monitoring and inappropriate to taper opioids. The panel was not certain about whether to increase opioids based on the patient’s account of what they need or transition to buprenorphine/naloxone.
For a patient with no history of opioid use disorder who was prescribed traditional opioids for pain and had a positive urine drug test for nonprescribed benzodiazepines, regardless of prognosis, the panel felt it was appropriate to continue opioids with close monitoring and inappropriate to taper opioids or transition to buprenorphine/naloxone.
The researchers said that improving education around buprenorphine and cancer pain management in the context of opioid use disorder or misuse is needed.
In a related editorial, two experts noted that the patients considered in this “important article” require considerable time and expertise from an interdisciplinary team.
“It is important that cancer centers establish and fund such teams mainly as a safety measure for these patients and also as a major contribution to the care of all patients with cancer,” wrote Joseph Arthur, MD, and Eduardo Bruera, MD, with the University of Texas MD Anderson Cancer Center, Houston.
In the wider context, Dr. Arthur and Dr. Bruera highlighted how treatments for patients with advanced cancer have evolved over the past 3 decades, yet patients have continued to be given opioids to address cancer-related pain. Developing more sophisticated drugs that relieve pain without significant side effects or addictive properties is imperative.
Dr. Arthur and Dr. Bruera said the study authors “appropriately emphasize the value of delivering compassionate and expert care for these particularly complex cases and the importance of conducting research on the best ways to alleviate the suffering in this rapidly growing patient population.”
This research was supported by Cambia Health Foundation and the National Institute of Nursing Research. Dr. Merlin, Dr. Arthur, and Dr. Bruera reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Opioids remain a staple in pain management for cancer, but there is little guidance around how to treat patients who have a history of opioid misuse.
Recently,
“There is a tendency to ignore treatment of opioid use disorder in advanced cancer patients because people think: ‘Oh, this person has bigger fish to fry,’ but that’s not a very patient-centric way of looking at things,” senior author Jessica Merlin, MD, PhD, with the University of Pittsburgh, said in a news release.
“We know that opioid use disorder is a really important factor in quality of life, so addressing opioid addiction and prescription opioid misuse in people with advanced cancer is really critical,” Dr. Merlin added.
The study was published online in JAMA Oncology.
To improve care for people with advanced cancer and cancer-related pain, the researchers first assessed how clinicians currently treat patients with opioid complexity.
Using an online Delphi platform, the team invited 120 clinicians with expertise in palliative care, pain management, and addiction medicine to weigh in on three common clinical scenarios – a patient with a recent history of untreated opioid use disorder, a patient taking more opioids than prescribed, and a patient using nonprescribed benzodiazepines.
For a patient with cancer and a recent history of untreated opioid use disorder, regardless of prognosis, the panel deemed it appropriate to begin treatment with buprenorphine/naloxone for pain but inappropriate to refer the patient to a methadone clinic. The panel felt that going to a methadone clinic would be too burdensome for a patient with advanced cancer and not possible for those with limited prognoses.
“This underscores the importance of access to [opioid use disorder] treatment in cancer treatment settings, including non–addiction specialists waivered to prescribe buprenorphine/naloxone and addiction specialists for more complex cases,” the authors wrote.
For a patient with untreated opioid use disorder, the panel deemed split-dose methadone (two to three times daily) appropriate in those with limited prognosis of weeks to months but was uncertain about the suitability of this approach for patients with longer prognoses of a year or longer.
The appropriateness of initiating treatment with a full-agonist opioid was considered uncertain for a patient with limited prognosis and inappropriate for a patient with longer prognosis.
For a patient with cancer pain and no medical history of opioid use disorder but taking more opioids than prescribed, regardless of prognosis, the panel felt it was appropriate to increase monitoring and inappropriate to taper opioids. The panel was not certain about whether to increase opioids based on the patient’s account of what they need or transition to buprenorphine/naloxone.
For a patient with no history of opioid use disorder who was prescribed traditional opioids for pain and had a positive urine drug test for nonprescribed benzodiazepines, regardless of prognosis, the panel felt it was appropriate to continue opioids with close monitoring and inappropriate to taper opioids or transition to buprenorphine/naloxone.
The researchers said that improving education around buprenorphine and cancer pain management in the context of opioid use disorder or misuse is needed.
In a related editorial, two experts noted that the patients considered in this “important article” require considerable time and expertise from an interdisciplinary team.
“It is important that cancer centers establish and fund such teams mainly as a safety measure for these patients and also as a major contribution to the care of all patients with cancer,” wrote Joseph Arthur, MD, and Eduardo Bruera, MD, with the University of Texas MD Anderson Cancer Center, Houston.
In the wider context, Dr. Arthur and Dr. Bruera highlighted how treatments for patients with advanced cancer have evolved over the past 3 decades, yet patients have continued to be given opioids to address cancer-related pain. Developing more sophisticated drugs that relieve pain without significant side effects or addictive properties is imperative.
Dr. Arthur and Dr. Bruera said the study authors “appropriately emphasize the value of delivering compassionate and expert care for these particularly complex cases and the importance of conducting research on the best ways to alleviate the suffering in this rapidly growing patient population.”
This research was supported by Cambia Health Foundation and the National Institute of Nursing Research. Dr. Merlin, Dr. Arthur, and Dr. Bruera reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Opioids remain a staple in pain management for cancer, but there is little guidance around how to treat patients who have a history of opioid misuse.
Recently,
“There is a tendency to ignore treatment of opioid use disorder in advanced cancer patients because people think: ‘Oh, this person has bigger fish to fry,’ but that’s not a very patient-centric way of looking at things,” senior author Jessica Merlin, MD, PhD, with the University of Pittsburgh, said in a news release.
“We know that opioid use disorder is a really important factor in quality of life, so addressing opioid addiction and prescription opioid misuse in people with advanced cancer is really critical,” Dr. Merlin added.
The study was published online in JAMA Oncology.
To improve care for people with advanced cancer and cancer-related pain, the researchers first assessed how clinicians currently treat patients with opioid complexity.
Using an online Delphi platform, the team invited 120 clinicians with expertise in palliative care, pain management, and addiction medicine to weigh in on three common clinical scenarios – a patient with a recent history of untreated opioid use disorder, a patient taking more opioids than prescribed, and a patient using nonprescribed benzodiazepines.
For a patient with cancer and a recent history of untreated opioid use disorder, regardless of prognosis, the panel deemed it appropriate to begin treatment with buprenorphine/naloxone for pain but inappropriate to refer the patient to a methadone clinic. The panel felt that going to a methadone clinic would be too burdensome for a patient with advanced cancer and not possible for those with limited prognoses.
“This underscores the importance of access to [opioid use disorder] treatment in cancer treatment settings, including non–addiction specialists waivered to prescribe buprenorphine/naloxone and addiction specialists for more complex cases,” the authors wrote.
For a patient with untreated opioid use disorder, the panel deemed split-dose methadone (two to three times daily) appropriate in those with limited prognosis of weeks to months but was uncertain about the suitability of this approach for patients with longer prognoses of a year or longer.
The appropriateness of initiating treatment with a full-agonist opioid was considered uncertain for a patient with limited prognosis and inappropriate for a patient with longer prognosis.
For a patient with cancer pain and no medical history of opioid use disorder but taking more opioids than prescribed, regardless of prognosis, the panel felt it was appropriate to increase monitoring and inappropriate to taper opioids. The panel was not certain about whether to increase opioids based on the patient’s account of what they need or transition to buprenorphine/naloxone.
For a patient with no history of opioid use disorder who was prescribed traditional opioids for pain and had a positive urine drug test for nonprescribed benzodiazepines, regardless of prognosis, the panel felt it was appropriate to continue opioids with close monitoring and inappropriate to taper opioids or transition to buprenorphine/naloxone.
The researchers said that improving education around buprenorphine and cancer pain management in the context of opioid use disorder or misuse is needed.
In a related editorial, two experts noted that the patients considered in this “important article” require considerable time and expertise from an interdisciplinary team.
“It is important that cancer centers establish and fund such teams mainly as a safety measure for these patients and also as a major contribution to the care of all patients with cancer,” wrote Joseph Arthur, MD, and Eduardo Bruera, MD, with the University of Texas MD Anderson Cancer Center, Houston.
In the wider context, Dr. Arthur and Dr. Bruera highlighted how treatments for patients with advanced cancer have evolved over the past 3 decades, yet patients have continued to be given opioids to address cancer-related pain. Developing more sophisticated drugs that relieve pain without significant side effects or addictive properties is imperative.
Dr. Arthur and Dr. Bruera said the study authors “appropriately emphasize the value of delivering compassionate and expert care for these particularly complex cases and the importance of conducting research on the best ways to alleviate the suffering in this rapidly growing patient population.”
This research was supported by Cambia Health Foundation and the National Institute of Nursing Research. Dr. Merlin, Dr. Arthur, and Dr. Bruera reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA ONCOLOGY
Head and neck tumor grade may predict response to immunotherapy
Findings from a cohort study highlight a potential role of tumor grade for predicting mucosal head and neck squamous cell carcinoma response to immunotherapy, researchers report in JAMA Otolaryngology–Head & Neck Surgery.
The analysis, which was among patients with either high-grade or low-grade recurrent or metastatic mucosal head and neck squamous cell carcinoma (HNSCC) tumors, revealed that tumor grade was independently associated with immunotherapy response.
“Generally, one would expect high-grade tumors to do worse because they are more aggressive,” said Rajarsi Mandal, MD, the study’s lead author. “But it’s thought that high-grade tumors have higher degrees of chromosomal instability with a lot more mutations generated throughout the genome of these tumors ... and we know that higher mutation rates correlate with higher responses to immunotherapy.”
Researchers found that the proportion of patients having a beneficial response to immunotherapy was larger for patients with high grade tumors (12 of 35; 34.3%) than those with low grade tumors (2 of 25, 8.0%) (difference, 26.3%; 95% confidence interval, 7.3%-45.3%). The odds of having a clinically beneficial response to immunotherapy was increased 5.35-fold (95% CI, 1.04-27.37) in patients with high-grade tumors. Among four patients with low-grade tumors and eight patients with high-grade tumors with available tumor mutational burden data, the mean tumor mutational burden was greater for patients with high-grade tumors (mean [standard deviation], 8.6 [5.4] mut/Mb; n = 8) than for patients with low grade tumors (mean [SD], 3.6 [1.1] mut/Mb; n = 4) (difference, 5.0 mut/Mb; 95% CI, −1.4 to 11.4 mut/Mb; Cohen d, 1.2).
“ said Dr. Mandal who is a head and neck cancer surgeon with the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore.
Previous studies of HNSCC tumors that are refractory to traditional therapies, including surgery, chemotherapy, and radiation therapy, have demonstrated a clinically beneficial response to immune checkpoint inhibitors (ICIs). An association between increased tumor mutational burden and beneficial response to ICIs has been shown in other cancers.
Researchers hypothesized that tumor histological grade may be associated with responses to immune checkpoint blockade, and designed their study to examine the association between tumor grade and immunotherapy response in patients treated with ICIs for recurrent or metastatic mucosal HNSCC.
In a single-center retrospective cohort study, investigators reviewed the medical records of 60 adult patients (mean age, 64.6 years; 85% male) with a primary mucosal HNSCC tumor treated with an immune checkpoint inhibitor (pembrolizumab, nivolumab, ipilimumab, or durvalumab) treated between July 1, 2015, and Jan. 22, 2020. They stratified them into those with low grade tumors (well differentiated and moderately differentiated) and those with high grade tumors (poorly differentiated). A clinically beneficial immunotherapy response, defined as complete response or partial response was the primary outcome.
Thirty-eight patients in the study cohort were current or former smokers. The most common primary tumor sight was at the oropharynx. Outcomes among those with high-grade tumors were improved, compared with those with low-grade tumors, for median progression-free survival (5.9 months vs. 3.3 months), median overall survival (16.6 months vs. 15.0 months, and risk of death (hazard ratio, 0.94).
The study’s main limitation was its small sample size and small number of patients who had a clinically beneficial immunotherapy response.
Dr. Mandal had no conflicts of interest to disclose.
Findings from a cohort study highlight a potential role of tumor grade for predicting mucosal head and neck squamous cell carcinoma response to immunotherapy, researchers report in JAMA Otolaryngology–Head & Neck Surgery.
The analysis, which was among patients with either high-grade or low-grade recurrent or metastatic mucosal head and neck squamous cell carcinoma (HNSCC) tumors, revealed that tumor grade was independently associated with immunotherapy response.
“Generally, one would expect high-grade tumors to do worse because they are more aggressive,” said Rajarsi Mandal, MD, the study’s lead author. “But it’s thought that high-grade tumors have higher degrees of chromosomal instability with a lot more mutations generated throughout the genome of these tumors ... and we know that higher mutation rates correlate with higher responses to immunotherapy.”
Researchers found that the proportion of patients having a beneficial response to immunotherapy was larger for patients with high grade tumors (12 of 35; 34.3%) than those with low grade tumors (2 of 25, 8.0%) (difference, 26.3%; 95% confidence interval, 7.3%-45.3%). The odds of having a clinically beneficial response to immunotherapy was increased 5.35-fold (95% CI, 1.04-27.37) in patients with high-grade tumors. Among four patients with low-grade tumors and eight patients with high-grade tumors with available tumor mutational burden data, the mean tumor mutational burden was greater for patients with high-grade tumors (mean [standard deviation], 8.6 [5.4] mut/Mb; n = 8) than for patients with low grade tumors (mean [SD], 3.6 [1.1] mut/Mb; n = 4) (difference, 5.0 mut/Mb; 95% CI, −1.4 to 11.4 mut/Mb; Cohen d, 1.2).
“ said Dr. Mandal who is a head and neck cancer surgeon with the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore.
Previous studies of HNSCC tumors that are refractory to traditional therapies, including surgery, chemotherapy, and radiation therapy, have demonstrated a clinically beneficial response to immune checkpoint inhibitors (ICIs). An association between increased tumor mutational burden and beneficial response to ICIs has been shown in other cancers.
Researchers hypothesized that tumor histological grade may be associated with responses to immune checkpoint blockade, and designed their study to examine the association between tumor grade and immunotherapy response in patients treated with ICIs for recurrent or metastatic mucosal HNSCC.
In a single-center retrospective cohort study, investigators reviewed the medical records of 60 adult patients (mean age, 64.6 years; 85% male) with a primary mucosal HNSCC tumor treated with an immune checkpoint inhibitor (pembrolizumab, nivolumab, ipilimumab, or durvalumab) treated between July 1, 2015, and Jan. 22, 2020. They stratified them into those with low grade tumors (well differentiated and moderately differentiated) and those with high grade tumors (poorly differentiated). A clinically beneficial immunotherapy response, defined as complete response or partial response was the primary outcome.
Thirty-eight patients in the study cohort were current or former smokers. The most common primary tumor sight was at the oropharynx. Outcomes among those with high-grade tumors were improved, compared with those with low-grade tumors, for median progression-free survival (5.9 months vs. 3.3 months), median overall survival (16.6 months vs. 15.0 months, and risk of death (hazard ratio, 0.94).
The study’s main limitation was its small sample size and small number of patients who had a clinically beneficial immunotherapy response.
Dr. Mandal had no conflicts of interest to disclose.
Findings from a cohort study highlight a potential role of tumor grade for predicting mucosal head and neck squamous cell carcinoma response to immunotherapy, researchers report in JAMA Otolaryngology–Head & Neck Surgery.
The analysis, which was among patients with either high-grade or low-grade recurrent or metastatic mucosal head and neck squamous cell carcinoma (HNSCC) tumors, revealed that tumor grade was independently associated with immunotherapy response.
“Generally, one would expect high-grade tumors to do worse because they are more aggressive,” said Rajarsi Mandal, MD, the study’s lead author. “But it’s thought that high-grade tumors have higher degrees of chromosomal instability with a lot more mutations generated throughout the genome of these tumors ... and we know that higher mutation rates correlate with higher responses to immunotherapy.”
Researchers found that the proportion of patients having a beneficial response to immunotherapy was larger for patients with high grade tumors (12 of 35; 34.3%) than those with low grade tumors (2 of 25, 8.0%) (difference, 26.3%; 95% confidence interval, 7.3%-45.3%). The odds of having a clinically beneficial response to immunotherapy was increased 5.35-fold (95% CI, 1.04-27.37) in patients with high-grade tumors. Among four patients with low-grade tumors and eight patients with high-grade tumors with available tumor mutational burden data, the mean tumor mutational burden was greater for patients with high-grade tumors (mean [standard deviation], 8.6 [5.4] mut/Mb; n = 8) than for patients with low grade tumors (mean [SD], 3.6 [1.1] mut/Mb; n = 4) (difference, 5.0 mut/Mb; 95% CI, −1.4 to 11.4 mut/Mb; Cohen d, 1.2).
“ said Dr. Mandal who is a head and neck cancer surgeon with the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore.
Previous studies of HNSCC tumors that are refractory to traditional therapies, including surgery, chemotherapy, and radiation therapy, have demonstrated a clinically beneficial response to immune checkpoint inhibitors (ICIs). An association between increased tumor mutational burden and beneficial response to ICIs has been shown in other cancers.
Researchers hypothesized that tumor histological grade may be associated with responses to immune checkpoint blockade, and designed their study to examine the association between tumor grade and immunotherapy response in patients treated with ICIs for recurrent or metastatic mucosal HNSCC.
In a single-center retrospective cohort study, investigators reviewed the medical records of 60 adult patients (mean age, 64.6 years; 85% male) with a primary mucosal HNSCC tumor treated with an immune checkpoint inhibitor (pembrolizumab, nivolumab, ipilimumab, or durvalumab) treated between July 1, 2015, and Jan. 22, 2020. They stratified them into those with low grade tumors (well differentiated and moderately differentiated) and those with high grade tumors (poorly differentiated). A clinically beneficial immunotherapy response, defined as complete response or partial response was the primary outcome.
Thirty-eight patients in the study cohort were current or former smokers. The most common primary tumor sight was at the oropharynx. Outcomes among those with high-grade tumors were improved, compared with those with low-grade tumors, for median progression-free survival (5.9 months vs. 3.3 months), median overall survival (16.6 months vs. 15.0 months, and risk of death (hazard ratio, 0.94).
The study’s main limitation was its small sample size and small number of patients who had a clinically beneficial immunotherapy response.
Dr. Mandal had no conflicts of interest to disclose.
FROM JAMA OTOLARYNGOLOGY – HEAD & NECK SURGERY
Experimental cancer drug promising for hospitalized COVID patients
, a new study shows.
The medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.
The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.
Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.
Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.
To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.
A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.
One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.
“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.
A version of this article first appeared on WebMD.com.
, a new study shows.
The medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.
The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.
Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.
Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.
To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.
A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.
One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.
“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.
A version of this article first appeared on WebMD.com.
, a new study shows.
The medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.
The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.
Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.
Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.
To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.
A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.
One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.
“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.
A version of this article first appeared on WebMD.com.
What explains poor adherence to eosinophilic esophagitis therapy?
Almost half of adult patients with eosinophilic esophagitis (EoE) reported poor adherence to long-term medical and dietary therapy, with age younger than 40 years and low necessity beliefs being the strongest predictors, a new study finds.
Clinicians need to spend more time discussing the need for EoE therapy with their patients, especially if they are younger, according to lead author Maria L. Haasnoot, MD, of Amsterdam University Medical Center (UMC), the Netherlands, and colleagues.
“Chronic treatment is necessary to maintain suppression of the inflammation and prevent negative outcomes in the long-term,” they write.
Until the recent approval of dupilumab (Dupixent) by the U.S. Food and Drug Administration, patients with EoE relied upon off-label options, including proton pump inhibitors and swallowed topical steroids, as well as dietary interventions for ongoing suppression of inflammation. But only about 1 in 6 patients achieve complete remission at 5 years, according to Dr. Haasnoot and colleagues.
“It is uncertain to what degree limited adherence to treatment [plays] a role in the limited long-term effects of treatment,” they write.
The findings were published online in American Journal of Gastroenterology.
Addressing a knowledge gap
The cross-sectional study involved 177 adult patients with EoE treated at Amsterdam UMC, who were prescribed dietary or medical maintenance therapy. Of note, some patients were treated with budesonide, which is approved for EoE in Europe but not in the United States.
Median participant age was 43 years, with a male-skewed distribution (71% men). Patients had been on EoE treatment for 2-6 years. Most (76%) were on medical treatments. Nearly half were on diets that avoided one to five food groups, with some on both medical treatments and elimination diets.
Using a link sent by mail, participants completed the online Medication Adherence Rating Scale, along with several other questionnaires, such as the Beliefs about Medicine Questionnaire, to measure secondary outcomes, including a patient’s view of how necessary or disruptive maintenance therapy is in their life.
The overall prevalence of poor adherence to therapy was high (41.8%), including a nonsignificant difference in adherence between medical and dietary therapies.
“It might come as a surprise that dietary-treated patients are certainly not less adherent to treatment than medically treated patients,” the authors write, noting that the opposite is usually true.
Multivariate logistic regression showed that patients younger than 40 years were more than twice as likely to be poorly adherent (odds ratio, 2.571; 95% confidence interval, 1.195-5.532). Those with low necessity beliefs were more than four times as likely to be poorly adherent (OR, 4.423; 95% CI, 2.169-9.016). Other factors linked to poor adherence were patients with longer disease duration and more severe symptoms.
“Clinicians should pay more attention to treatment adherence, particularly in younger patients,” the authors conclude. “The necessity of treatment should be actively discussed, and efforts should be done to take doubts away, as this may improve treatment adherence and subsequently may improve treatment effects and long-term outcomes.”
More patient education needed
According to Jennifer L. Horsley-Silva, MD, of Mayo Clinic, Scottsdale, Ariz., “This study is important, as it is one of the first studies to investigate the rate of treatment adherence in EoE patients and attempts to identify factors associated with adherence both in medically and dietary treated patients.”
Dr. Horsley-Silva commented that the findings align with recent research she and her colleagues conducted at the Mayo Clinic, where few patients successfully completed a six-food elimination diet, even when paired with a dietitian. As with the present study, success trended lower among younger adults. “These findings highlight the need for physicians treating EoE to motivate all patients, but especially younger patients, by discussing disease pathophysiology and explaining the reason for maintenance treatment early on,” Dr. Horsley-Silva said.
Conversations should also address the discordance between symptoms and histologic disease, patient doubts and concerns, and other barriers to adherence, she noted.
“Shared decisionmaking is of utmost importance when deciding upon a maintenance treatment strategy and should be readdressed continually,” she added.
Gary W. Falk, MD, of Penn Medicine, Philadelphia, said that patients with EoE may be poorly adherent because therapies tend to be complicated and people often forget to take their medications, especially when their symptoms improve, even though this is a poor indicator of underlying disease. The discordance between symptoms and histology is “not commonly appreciated by the EoE GI community,” he noted.
Patients may benefit from knowing that untreated or undertreated EoE increases the risk for strictures and stenoses, need for dilation, and frequency of food bolus impactions, Dr. Falk said.
“The other thing we know is that once someone is induced into remission, and they stay on therapy ... long-term remission can be maintained,” he added.
The impact of Dupilumab
John Leung, MD, of Boston Food Allergy Center, also cited the complexities of EoE therapies as reason for poor adherence, though he believes this paradigm will shift now that dupilumab has been approved. Dupilumab injections are “just once a week, so it’s much easier in terms of frequency,” Dr. Leung said. “I would expect that the compliance [for dupilumab] will be better” than for older therapies.
Dr. Leung, who helped conduct the dupilumab clinical trials contributing to its approval for EoE and receives speaking honoraria from manufacturer Regeneron/Sanofi, said that dupilumab also overcomes the challenges with elimination diets while offering relief for concomitant conditions, such as “asthma, eczema, food allergies, and seasonal allergies.”
But Dr. Falk, who also worked on the dupilumab clinical trials, said the situation is “not straightforward,” even with FDA approval.
“There are going to be significant costs with [prescribing dupilumab], because it’s a biologic,” Dr. Falk said.
Dr. Falk also pointed out that prior authorization will be required, and until more studies can be conducted, the true impact of once-weekly dosing versus daily dosing remains unknown.
“I would say [dupilumab] has the potential to improve adherence, but we need to see if that’s going to be the case or not,” Dr. Falk said.
The authors disclosed relationships with Dr. Falk Pharma, AstraZeneca, and Sanofi/Regeneron (the manufacturers of Dupixent [dupilumab]), among others. Dr. Horsley-Silva, Dr. Falk, and Dr. Leung conducted clinical trials for dupilumab on behalf of Sanofi/Regeneron, with Dr. Leung also disclosing speaking honoraria from Sanofi/Regeneron. Dr. Horsley-Silva has acted as a clinical trial site principal investigator for Allakos and Celgene/Bristol-Myers Squibb.
A version of this article first appeared on Medscape.com.
Almost half of adult patients with eosinophilic esophagitis (EoE) reported poor adherence to long-term medical and dietary therapy, with age younger than 40 years and low necessity beliefs being the strongest predictors, a new study finds.
Clinicians need to spend more time discussing the need for EoE therapy with their patients, especially if they are younger, according to lead author Maria L. Haasnoot, MD, of Amsterdam University Medical Center (UMC), the Netherlands, and colleagues.
“Chronic treatment is necessary to maintain suppression of the inflammation and prevent negative outcomes in the long-term,” they write.
Until the recent approval of dupilumab (Dupixent) by the U.S. Food and Drug Administration, patients with EoE relied upon off-label options, including proton pump inhibitors and swallowed topical steroids, as well as dietary interventions for ongoing suppression of inflammation. But only about 1 in 6 patients achieve complete remission at 5 years, according to Dr. Haasnoot and colleagues.
“It is uncertain to what degree limited adherence to treatment [plays] a role in the limited long-term effects of treatment,” they write.
The findings were published online in American Journal of Gastroenterology.
Addressing a knowledge gap
The cross-sectional study involved 177 adult patients with EoE treated at Amsterdam UMC, who were prescribed dietary or medical maintenance therapy. Of note, some patients were treated with budesonide, which is approved for EoE in Europe but not in the United States.
Median participant age was 43 years, with a male-skewed distribution (71% men). Patients had been on EoE treatment for 2-6 years. Most (76%) were on medical treatments. Nearly half were on diets that avoided one to five food groups, with some on both medical treatments and elimination diets.
Using a link sent by mail, participants completed the online Medication Adherence Rating Scale, along with several other questionnaires, such as the Beliefs about Medicine Questionnaire, to measure secondary outcomes, including a patient’s view of how necessary or disruptive maintenance therapy is in their life.
The overall prevalence of poor adherence to therapy was high (41.8%), including a nonsignificant difference in adherence between medical and dietary therapies.
“It might come as a surprise that dietary-treated patients are certainly not less adherent to treatment than medically treated patients,” the authors write, noting that the opposite is usually true.
Multivariate logistic regression showed that patients younger than 40 years were more than twice as likely to be poorly adherent (odds ratio, 2.571; 95% confidence interval, 1.195-5.532). Those with low necessity beliefs were more than four times as likely to be poorly adherent (OR, 4.423; 95% CI, 2.169-9.016). Other factors linked to poor adherence were patients with longer disease duration and more severe symptoms.
“Clinicians should pay more attention to treatment adherence, particularly in younger patients,” the authors conclude. “The necessity of treatment should be actively discussed, and efforts should be done to take doubts away, as this may improve treatment adherence and subsequently may improve treatment effects and long-term outcomes.”
More patient education needed
According to Jennifer L. Horsley-Silva, MD, of Mayo Clinic, Scottsdale, Ariz., “This study is important, as it is one of the first studies to investigate the rate of treatment adherence in EoE patients and attempts to identify factors associated with adherence both in medically and dietary treated patients.”
Dr. Horsley-Silva commented that the findings align with recent research she and her colleagues conducted at the Mayo Clinic, where few patients successfully completed a six-food elimination diet, even when paired with a dietitian. As with the present study, success trended lower among younger adults. “These findings highlight the need for physicians treating EoE to motivate all patients, but especially younger patients, by discussing disease pathophysiology and explaining the reason for maintenance treatment early on,” Dr. Horsley-Silva said.
Conversations should also address the discordance between symptoms and histologic disease, patient doubts and concerns, and other barriers to adherence, she noted.
“Shared decisionmaking is of utmost importance when deciding upon a maintenance treatment strategy and should be readdressed continually,” she added.
Gary W. Falk, MD, of Penn Medicine, Philadelphia, said that patients with EoE may be poorly adherent because therapies tend to be complicated and people often forget to take their medications, especially when their symptoms improve, even though this is a poor indicator of underlying disease. The discordance between symptoms and histology is “not commonly appreciated by the EoE GI community,” he noted.
Patients may benefit from knowing that untreated or undertreated EoE increases the risk for strictures and stenoses, need for dilation, and frequency of food bolus impactions, Dr. Falk said.
“The other thing we know is that once someone is induced into remission, and they stay on therapy ... long-term remission can be maintained,” he added.
The impact of Dupilumab
John Leung, MD, of Boston Food Allergy Center, also cited the complexities of EoE therapies as reason for poor adherence, though he believes this paradigm will shift now that dupilumab has been approved. Dupilumab injections are “just once a week, so it’s much easier in terms of frequency,” Dr. Leung said. “I would expect that the compliance [for dupilumab] will be better” than for older therapies.
Dr. Leung, who helped conduct the dupilumab clinical trials contributing to its approval for EoE and receives speaking honoraria from manufacturer Regeneron/Sanofi, said that dupilumab also overcomes the challenges with elimination diets while offering relief for concomitant conditions, such as “asthma, eczema, food allergies, and seasonal allergies.”
But Dr. Falk, who also worked on the dupilumab clinical trials, said the situation is “not straightforward,” even with FDA approval.
“There are going to be significant costs with [prescribing dupilumab], because it’s a biologic,” Dr. Falk said.
Dr. Falk also pointed out that prior authorization will be required, and until more studies can be conducted, the true impact of once-weekly dosing versus daily dosing remains unknown.
“I would say [dupilumab] has the potential to improve adherence, but we need to see if that’s going to be the case or not,” Dr. Falk said.
The authors disclosed relationships with Dr. Falk Pharma, AstraZeneca, and Sanofi/Regeneron (the manufacturers of Dupixent [dupilumab]), among others. Dr. Horsley-Silva, Dr. Falk, and Dr. Leung conducted clinical trials for dupilumab on behalf of Sanofi/Regeneron, with Dr. Leung also disclosing speaking honoraria from Sanofi/Regeneron. Dr. Horsley-Silva has acted as a clinical trial site principal investigator for Allakos and Celgene/Bristol-Myers Squibb.
A version of this article first appeared on Medscape.com.
Almost half of adult patients with eosinophilic esophagitis (EoE) reported poor adherence to long-term medical and dietary therapy, with age younger than 40 years and low necessity beliefs being the strongest predictors, a new study finds.
Clinicians need to spend more time discussing the need for EoE therapy with their patients, especially if they are younger, according to lead author Maria L. Haasnoot, MD, of Amsterdam University Medical Center (UMC), the Netherlands, and colleagues.
“Chronic treatment is necessary to maintain suppression of the inflammation and prevent negative outcomes in the long-term,” they write.
Until the recent approval of dupilumab (Dupixent) by the U.S. Food and Drug Administration, patients with EoE relied upon off-label options, including proton pump inhibitors and swallowed topical steroids, as well as dietary interventions for ongoing suppression of inflammation. But only about 1 in 6 patients achieve complete remission at 5 years, according to Dr. Haasnoot and colleagues.
“It is uncertain to what degree limited adherence to treatment [plays] a role in the limited long-term effects of treatment,” they write.
The findings were published online in American Journal of Gastroenterology.
Addressing a knowledge gap
The cross-sectional study involved 177 adult patients with EoE treated at Amsterdam UMC, who were prescribed dietary or medical maintenance therapy. Of note, some patients were treated with budesonide, which is approved for EoE in Europe but not in the United States.
Median participant age was 43 years, with a male-skewed distribution (71% men). Patients had been on EoE treatment for 2-6 years. Most (76%) were on medical treatments. Nearly half were on diets that avoided one to five food groups, with some on both medical treatments and elimination diets.
Using a link sent by mail, participants completed the online Medication Adherence Rating Scale, along with several other questionnaires, such as the Beliefs about Medicine Questionnaire, to measure secondary outcomes, including a patient’s view of how necessary or disruptive maintenance therapy is in their life.
The overall prevalence of poor adherence to therapy was high (41.8%), including a nonsignificant difference in adherence between medical and dietary therapies.
“It might come as a surprise that dietary-treated patients are certainly not less adherent to treatment than medically treated patients,” the authors write, noting that the opposite is usually true.
Multivariate logistic regression showed that patients younger than 40 years were more than twice as likely to be poorly adherent (odds ratio, 2.571; 95% confidence interval, 1.195-5.532). Those with low necessity beliefs were more than four times as likely to be poorly adherent (OR, 4.423; 95% CI, 2.169-9.016). Other factors linked to poor adherence were patients with longer disease duration and more severe symptoms.
“Clinicians should pay more attention to treatment adherence, particularly in younger patients,” the authors conclude. “The necessity of treatment should be actively discussed, and efforts should be done to take doubts away, as this may improve treatment adherence and subsequently may improve treatment effects and long-term outcomes.”
More patient education needed
According to Jennifer L. Horsley-Silva, MD, of Mayo Clinic, Scottsdale, Ariz., “This study is important, as it is one of the first studies to investigate the rate of treatment adherence in EoE patients and attempts to identify factors associated with adherence both in medically and dietary treated patients.”
Dr. Horsley-Silva commented that the findings align with recent research she and her colleagues conducted at the Mayo Clinic, where few patients successfully completed a six-food elimination diet, even when paired with a dietitian. As with the present study, success trended lower among younger adults. “These findings highlight the need for physicians treating EoE to motivate all patients, but especially younger patients, by discussing disease pathophysiology and explaining the reason for maintenance treatment early on,” Dr. Horsley-Silva said.
Conversations should also address the discordance between symptoms and histologic disease, patient doubts and concerns, and other barriers to adherence, she noted.
“Shared decisionmaking is of utmost importance when deciding upon a maintenance treatment strategy and should be readdressed continually,” she added.
Gary W. Falk, MD, of Penn Medicine, Philadelphia, said that patients with EoE may be poorly adherent because therapies tend to be complicated and people often forget to take their medications, especially when their symptoms improve, even though this is a poor indicator of underlying disease. The discordance between symptoms and histology is “not commonly appreciated by the EoE GI community,” he noted.
Patients may benefit from knowing that untreated or undertreated EoE increases the risk for strictures and stenoses, need for dilation, and frequency of food bolus impactions, Dr. Falk said.
“The other thing we know is that once someone is induced into remission, and they stay on therapy ... long-term remission can be maintained,” he added.
The impact of Dupilumab
John Leung, MD, of Boston Food Allergy Center, also cited the complexities of EoE therapies as reason for poor adherence, though he believes this paradigm will shift now that dupilumab has been approved. Dupilumab injections are “just once a week, so it’s much easier in terms of frequency,” Dr. Leung said. “I would expect that the compliance [for dupilumab] will be better” than for older therapies.
Dr. Leung, who helped conduct the dupilumab clinical trials contributing to its approval for EoE and receives speaking honoraria from manufacturer Regeneron/Sanofi, said that dupilumab also overcomes the challenges with elimination diets while offering relief for concomitant conditions, such as “asthma, eczema, food allergies, and seasonal allergies.”
But Dr. Falk, who also worked on the dupilumab clinical trials, said the situation is “not straightforward,” even with FDA approval.
“There are going to be significant costs with [prescribing dupilumab], because it’s a biologic,” Dr. Falk said.
Dr. Falk also pointed out that prior authorization will be required, and until more studies can be conducted, the true impact of once-weekly dosing versus daily dosing remains unknown.
“I would say [dupilumab] has the potential to improve adherence, but we need to see if that’s going to be the case or not,” Dr. Falk said.
The authors disclosed relationships with Dr. Falk Pharma, AstraZeneca, and Sanofi/Regeneron (the manufacturers of Dupixent [dupilumab]), among others. Dr. Horsley-Silva, Dr. Falk, and Dr. Leung conducted clinical trials for dupilumab on behalf of Sanofi/Regeneron, with Dr. Leung also disclosing speaking honoraria from Sanofi/Regeneron. Dr. Horsley-Silva has acted as a clinical trial site principal investigator for Allakos and Celgene/Bristol-Myers Squibb.
A version of this article first appeared on Medscape.com.
Doctors still overprescribing fluoroquinolones despite risks
When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.
Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.
“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.
Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.
That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.
The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.
Yet despite the many patient reports and FDA warnings on dangerous side effects, better treated with less risky antibiotics.
“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA warnings on fluoroquinolones
Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.
FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.
Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.
- In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
- In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
- In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
- And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.
But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should guidelines be stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.
For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
What you can do
Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.
Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:
- For what condition is this medication prescribed, and is there another drug specific to my condition?
- What are the risks associated with this medication, and do the benefits outweigh them?
- Will this medication interact with my other drugs and/or other health conditions?
- What are the “boxed” warnings for this medication, and where can I report adverse events?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”
Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
A version of this article first appeared on WebMD.com.
When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.
Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.
“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.
Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.
That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.
The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.
Yet despite the many patient reports and FDA warnings on dangerous side effects, better treated with less risky antibiotics.
“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA warnings on fluoroquinolones
Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.
FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.
Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.
- In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
- In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
- In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
- And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.
But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should guidelines be stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.
For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
What you can do
Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.
Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:
- For what condition is this medication prescribed, and is there another drug specific to my condition?
- What are the risks associated with this medication, and do the benefits outweigh them?
- Will this medication interact with my other drugs and/or other health conditions?
- What are the “boxed” warnings for this medication, and where can I report adverse events?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”
Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
A version of this article first appeared on WebMD.com.
When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.
Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.
“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.
Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.
That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.
The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.
Yet despite the many patient reports and FDA warnings on dangerous side effects, better treated with less risky antibiotics.
“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA warnings on fluoroquinolones
Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.
FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.
Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.
- In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
- In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
- In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
- And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.
But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should guidelines be stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.
For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
What you can do
Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.
Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:
- For what condition is this medication prescribed, and is there another drug specific to my condition?
- What are the risks associated with this medication, and do the benefits outweigh them?
- Will this medication interact with my other drugs and/or other health conditions?
- What are the “boxed” warnings for this medication, and where can I report adverse events?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”
Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
A version of this article first appeared on WebMD.com.
Statins in NAFLD: Taking a closer look at benefits
LONDON – Substantial reductions in liver fat and fibrosis can be achieved with statin therapy, according to research presented at the annual International Liver Congress sponsored by the European Association for the Study of the Liver.
Statins are thought to have multiple beneficial actions in people with fatty liver disease, but there has been little insight into how they may be exerting such effects.
Now, data from the Rotterdam Study and others suggest that statins may be reducing the formation of lipid droplets as well as influencing the expression of important inflammatory genes.
The results “require further confirmation,” the team behind the work said, which was done at Erasmus Medical Center in Rotterdam, the Netherlands, in collaboration with researchers at The First Affiliated Hospital of Wenzhou (China) Medical University.
“Statins are inversely associated with multiple components of the NAFLD [nonalcoholic fatty liver disease] spectrum,” said Ibrahim Ayada, a PhD student in the department of gastroenterology and hepatology at Erasmus MC.
“Statins can inhibit lipid synthesis in organoids and statins also exhibit healthy inflammatory effects, which might contribute to the hepatoprotective effects that we observe in our population studies,” Mr. Ayada said.
A rising problem that needs addressing
Together NAFLD and NASH constitute a significant and increasing health burden, Mr. Ayada observed, noting that there were an estimated 64 million people in the United States and 52 million people in Europe, at least, with the rise mirroring the obesity pandemic.
“The number of patients visiting outpatient clinics has nearly doubled within a study period of 5 years,” he said.
“There is no pharmacologic therapy,” he reminded his audience, observing that fatty liver disease was a major indication for liver transplantation.
Statins are a long-standing staple of cardiovascular disease management and are known to have pleiotropic effects, Mr. Ayada explained. Their use in NAFLD and non-alcoholic steatohepatitis (NASH) has been purported but is supported by inconclusive evidence.
Indeed, a prior Cochrane review performed in 2013 found only two studies that were eligible for analysis and had “high risk of bias and a small numbers of participants,” according to the review’s authors.
Examining the connection
To look at the possible benefits of statins in people with NASH and examine how these effects might be occurring, Mr. Ayada and collaborators first took data from the Rotterdam Study, a large population-based prospective cohort that has been collecting data on its participants since the early 90s.
Data on over 4,500 participants were examined and of these, just over 1,000 had NAFLD. Statin versus no statin use was found to be associated with around a 30% reduction in fatty liver disease, with an odds ratio or 0.72 for NAFLD.
Then, looking only at a subset of patients with biopsy-proven NAFLD, statin use was associated with a 45% reduction in NASH (OR, 0.55) and a 24% reduction in fibrosis, although only the NASH reduction was significant (P = .031). The purpose of this cohort is to look at potential biomarkers and all participants had donated blood, urine, and stool samples; all were of Chinese descent, Mr. Ayada said.
“We then pooled our results with existing evidence in a meta-analysis,” said Mr. Ayada, including 16 studies. While results showed an overall inverse association, only the findings for a reduction in NAFLD and fibrosis were significant; the relationship between statins and NASH was not significant.
Investigating mechanistic effects
Then, for the second part of their work, Mr. Ayada and associates looked at potential mechanistic effects of statins.
“We did part two because we knew part one was going to be cross-sectional and we could only show the association and not causality, so we tried to shed some light on possible pathways,” he said.
To do this they used a novel model of liver organoids developed to study fatty liver disease and test potential therapeutics. In this model human liver organoids are exposed to sodium lactate, sodium pyruvate, and octanoic acid, which induce the formation of lipid droplets. Exposing the organoids to statins – simvastatin and lovastatin were used in the experiments – resulted in a reduced number of the induced lipid droplets.
“Although all concentrations of statins significantly inhibited the lipid size versus the control, the major effect was quite modest,” observed Mr. Ayada. The effect was most noticeable at the highest dose used (10 micromolar), and what they think might be happening is that the statins are clearing the smaller droplets first, leaving the larger ones behind.
Next, they looked at the effect of statin treatment on inflammatory gene expression in liver-derived monocytes. These will turn into macrophages and play a key role in chronic inflammation, Mr. Ayada explained. Initial results suggest that several proinflammatory cytokines such as interleukin-1 beta, IL-6, and IL-8 may be downplayed by statin therapy.
An anti-inflammatory effect of statins was also reported in unrelated poster presentations at the congress. While researchers Seul Ki Han and associated from South Korea showed an anti-inflammatory effect of a combination of simvastatin and ezetimibe (SAT083), a Dutch team found that atorvastatin reduced the infiltration of hepatic macrophages, neutrophils, and monocytes, as well as lowering levels of proinflammatory cytokines (SAT033).
Statins for NASH – a missed opportunity?
“As far as I am aware there is no robust evidence from large, randomized trials to suggest statins lessen chances of NAFLD, or improve its surrogate markers such as ALT or GGT [gamma-glutamyltransferase] levels,” Naveed Sattar, PhD, FRCP, FRCPath, FRSE, FMedSci, commented in an interview.
“The Rotterdam study is merely cross-sectional and cannot answer the question of causality,” added Dr. Sattar, who is professor of metabolic medicine and Honorary Consultant in Cardiovascular & Medical Science at the University of Glasgow. “It may be people who have less NAFLD are more likely to be prescribed statins, perhaps because doctors are wary of prescribing statins to those with slightly deranged liver tests,” he qualified.
Moreover, said Dr. Sattar, “prior evidence shows statins are underused in people with heart disease but who have NAFLD, which represents a missed opportunity to prevent heart disease.
“If statins had positive effects for preventing conversion of NAFLD to NASH or lessening fibrosis, I believe we would have known that by now.”
As for use of statins in future treatments of fatty liver disease, Dr. Sattar said: “I would not pin my hopes on statins to improve liver health, but doctors need to remember statins are safe in people with NAFLD or NASH and they should not be withheld in those who have existing cardiovascular disease or at elevated risk.”
The study received no commercial funding. Mr. Ayada and Dr. Sattar had no relevant conflicts of interest.
LONDON – Substantial reductions in liver fat and fibrosis can be achieved with statin therapy, according to research presented at the annual International Liver Congress sponsored by the European Association for the Study of the Liver.
Statins are thought to have multiple beneficial actions in people with fatty liver disease, but there has been little insight into how they may be exerting such effects.
Now, data from the Rotterdam Study and others suggest that statins may be reducing the formation of lipid droplets as well as influencing the expression of important inflammatory genes.
The results “require further confirmation,” the team behind the work said, which was done at Erasmus Medical Center in Rotterdam, the Netherlands, in collaboration with researchers at The First Affiliated Hospital of Wenzhou (China) Medical University.
“Statins are inversely associated with multiple components of the NAFLD [nonalcoholic fatty liver disease] spectrum,” said Ibrahim Ayada, a PhD student in the department of gastroenterology and hepatology at Erasmus MC.
“Statins can inhibit lipid synthesis in organoids and statins also exhibit healthy inflammatory effects, which might contribute to the hepatoprotective effects that we observe in our population studies,” Mr. Ayada said.
A rising problem that needs addressing
Together NAFLD and NASH constitute a significant and increasing health burden, Mr. Ayada observed, noting that there were an estimated 64 million people in the United States and 52 million people in Europe, at least, with the rise mirroring the obesity pandemic.
“The number of patients visiting outpatient clinics has nearly doubled within a study period of 5 years,” he said.
“There is no pharmacologic therapy,” he reminded his audience, observing that fatty liver disease was a major indication for liver transplantation.
Statins are a long-standing staple of cardiovascular disease management and are known to have pleiotropic effects, Mr. Ayada explained. Their use in NAFLD and non-alcoholic steatohepatitis (NASH) has been purported but is supported by inconclusive evidence.
Indeed, a prior Cochrane review performed in 2013 found only two studies that were eligible for analysis and had “high risk of bias and a small numbers of participants,” according to the review’s authors.
Examining the connection
To look at the possible benefits of statins in people with NASH and examine how these effects might be occurring, Mr. Ayada and collaborators first took data from the Rotterdam Study, a large population-based prospective cohort that has been collecting data on its participants since the early 90s.
Data on over 4,500 participants were examined and of these, just over 1,000 had NAFLD. Statin versus no statin use was found to be associated with around a 30% reduction in fatty liver disease, with an odds ratio or 0.72 for NAFLD.
Then, looking only at a subset of patients with biopsy-proven NAFLD, statin use was associated with a 45% reduction in NASH (OR, 0.55) and a 24% reduction in fibrosis, although only the NASH reduction was significant (P = .031). The purpose of this cohort is to look at potential biomarkers and all participants had donated blood, urine, and stool samples; all were of Chinese descent, Mr. Ayada said.
“We then pooled our results with existing evidence in a meta-analysis,” said Mr. Ayada, including 16 studies. While results showed an overall inverse association, only the findings for a reduction in NAFLD and fibrosis were significant; the relationship between statins and NASH was not significant.
Investigating mechanistic effects
Then, for the second part of their work, Mr. Ayada and associates looked at potential mechanistic effects of statins.
“We did part two because we knew part one was going to be cross-sectional and we could only show the association and not causality, so we tried to shed some light on possible pathways,” he said.
To do this they used a novel model of liver organoids developed to study fatty liver disease and test potential therapeutics. In this model human liver organoids are exposed to sodium lactate, sodium pyruvate, and octanoic acid, which induce the formation of lipid droplets. Exposing the organoids to statins – simvastatin and lovastatin were used in the experiments – resulted in a reduced number of the induced lipid droplets.
“Although all concentrations of statins significantly inhibited the lipid size versus the control, the major effect was quite modest,” observed Mr. Ayada. The effect was most noticeable at the highest dose used (10 micromolar), and what they think might be happening is that the statins are clearing the smaller droplets first, leaving the larger ones behind.
Next, they looked at the effect of statin treatment on inflammatory gene expression in liver-derived monocytes. These will turn into macrophages and play a key role in chronic inflammation, Mr. Ayada explained. Initial results suggest that several proinflammatory cytokines such as interleukin-1 beta, IL-6, and IL-8 may be downplayed by statin therapy.
An anti-inflammatory effect of statins was also reported in unrelated poster presentations at the congress. While researchers Seul Ki Han and associated from South Korea showed an anti-inflammatory effect of a combination of simvastatin and ezetimibe (SAT083), a Dutch team found that atorvastatin reduced the infiltration of hepatic macrophages, neutrophils, and monocytes, as well as lowering levels of proinflammatory cytokines (SAT033).
Statins for NASH – a missed opportunity?
“As far as I am aware there is no robust evidence from large, randomized trials to suggest statins lessen chances of NAFLD, or improve its surrogate markers such as ALT or GGT [gamma-glutamyltransferase] levels,” Naveed Sattar, PhD, FRCP, FRCPath, FRSE, FMedSci, commented in an interview.
“The Rotterdam study is merely cross-sectional and cannot answer the question of causality,” added Dr. Sattar, who is professor of metabolic medicine and Honorary Consultant in Cardiovascular & Medical Science at the University of Glasgow. “It may be people who have less NAFLD are more likely to be prescribed statins, perhaps because doctors are wary of prescribing statins to those with slightly deranged liver tests,” he qualified.
Moreover, said Dr. Sattar, “prior evidence shows statins are underused in people with heart disease but who have NAFLD, which represents a missed opportunity to prevent heart disease.
“If statins had positive effects for preventing conversion of NAFLD to NASH or lessening fibrosis, I believe we would have known that by now.”
As for use of statins in future treatments of fatty liver disease, Dr. Sattar said: “I would not pin my hopes on statins to improve liver health, but doctors need to remember statins are safe in people with NAFLD or NASH and they should not be withheld in those who have existing cardiovascular disease or at elevated risk.”
The study received no commercial funding. Mr. Ayada and Dr. Sattar had no relevant conflicts of interest.
LONDON – Substantial reductions in liver fat and fibrosis can be achieved with statin therapy, according to research presented at the annual International Liver Congress sponsored by the European Association for the Study of the Liver.
Statins are thought to have multiple beneficial actions in people with fatty liver disease, but there has been little insight into how they may be exerting such effects.
Now, data from the Rotterdam Study and others suggest that statins may be reducing the formation of lipid droplets as well as influencing the expression of important inflammatory genes.
The results “require further confirmation,” the team behind the work said, which was done at Erasmus Medical Center in Rotterdam, the Netherlands, in collaboration with researchers at The First Affiliated Hospital of Wenzhou (China) Medical University.
“Statins are inversely associated with multiple components of the NAFLD [nonalcoholic fatty liver disease] spectrum,” said Ibrahim Ayada, a PhD student in the department of gastroenterology and hepatology at Erasmus MC.
“Statins can inhibit lipid synthesis in organoids and statins also exhibit healthy inflammatory effects, which might contribute to the hepatoprotective effects that we observe in our population studies,” Mr. Ayada said.
A rising problem that needs addressing
Together NAFLD and NASH constitute a significant and increasing health burden, Mr. Ayada observed, noting that there were an estimated 64 million people in the United States and 52 million people in Europe, at least, with the rise mirroring the obesity pandemic.
“The number of patients visiting outpatient clinics has nearly doubled within a study period of 5 years,” he said.
“There is no pharmacologic therapy,” he reminded his audience, observing that fatty liver disease was a major indication for liver transplantation.
Statins are a long-standing staple of cardiovascular disease management and are known to have pleiotropic effects, Mr. Ayada explained. Their use in NAFLD and non-alcoholic steatohepatitis (NASH) has been purported but is supported by inconclusive evidence.
Indeed, a prior Cochrane review performed in 2013 found only two studies that were eligible for analysis and had “high risk of bias and a small numbers of participants,” according to the review’s authors.
Examining the connection
To look at the possible benefits of statins in people with NASH and examine how these effects might be occurring, Mr. Ayada and collaborators first took data from the Rotterdam Study, a large population-based prospective cohort that has been collecting data on its participants since the early 90s.
Data on over 4,500 participants were examined and of these, just over 1,000 had NAFLD. Statin versus no statin use was found to be associated with around a 30% reduction in fatty liver disease, with an odds ratio or 0.72 for NAFLD.
Then, looking only at a subset of patients with biopsy-proven NAFLD, statin use was associated with a 45% reduction in NASH (OR, 0.55) and a 24% reduction in fibrosis, although only the NASH reduction was significant (P = .031). The purpose of this cohort is to look at potential biomarkers and all participants had donated blood, urine, and stool samples; all were of Chinese descent, Mr. Ayada said.
“We then pooled our results with existing evidence in a meta-analysis,” said Mr. Ayada, including 16 studies. While results showed an overall inverse association, only the findings for a reduction in NAFLD and fibrosis were significant; the relationship between statins and NASH was not significant.
Investigating mechanistic effects
Then, for the second part of their work, Mr. Ayada and associates looked at potential mechanistic effects of statins.
“We did part two because we knew part one was going to be cross-sectional and we could only show the association and not causality, so we tried to shed some light on possible pathways,” he said.
To do this they used a novel model of liver organoids developed to study fatty liver disease and test potential therapeutics. In this model human liver organoids are exposed to sodium lactate, sodium pyruvate, and octanoic acid, which induce the formation of lipid droplets. Exposing the organoids to statins – simvastatin and lovastatin were used in the experiments – resulted in a reduced number of the induced lipid droplets.
“Although all concentrations of statins significantly inhibited the lipid size versus the control, the major effect was quite modest,” observed Mr. Ayada. The effect was most noticeable at the highest dose used (10 micromolar), and what they think might be happening is that the statins are clearing the smaller droplets first, leaving the larger ones behind.
Next, they looked at the effect of statin treatment on inflammatory gene expression in liver-derived monocytes. These will turn into macrophages and play a key role in chronic inflammation, Mr. Ayada explained. Initial results suggest that several proinflammatory cytokines such as interleukin-1 beta, IL-6, and IL-8 may be downplayed by statin therapy.
An anti-inflammatory effect of statins was also reported in unrelated poster presentations at the congress. While researchers Seul Ki Han and associated from South Korea showed an anti-inflammatory effect of a combination of simvastatin and ezetimibe (SAT083), a Dutch team found that atorvastatin reduced the infiltration of hepatic macrophages, neutrophils, and monocytes, as well as lowering levels of proinflammatory cytokines (SAT033).
Statins for NASH – a missed opportunity?
“As far as I am aware there is no robust evidence from large, randomized trials to suggest statins lessen chances of NAFLD, or improve its surrogate markers such as ALT or GGT [gamma-glutamyltransferase] levels,” Naveed Sattar, PhD, FRCP, FRCPath, FRSE, FMedSci, commented in an interview.
“The Rotterdam study is merely cross-sectional and cannot answer the question of causality,” added Dr. Sattar, who is professor of metabolic medicine and Honorary Consultant in Cardiovascular & Medical Science at the University of Glasgow. “It may be people who have less NAFLD are more likely to be prescribed statins, perhaps because doctors are wary of prescribing statins to those with slightly deranged liver tests,” he qualified.
Moreover, said Dr. Sattar, “prior evidence shows statins are underused in people with heart disease but who have NAFLD, which represents a missed opportunity to prevent heart disease.
“If statins had positive effects for preventing conversion of NAFLD to NASH or lessening fibrosis, I believe we would have known that by now.”
As for use of statins in future treatments of fatty liver disease, Dr. Sattar said: “I would not pin my hopes on statins to improve liver health, but doctors need to remember statins are safe in people with NAFLD or NASH and they should not be withheld in those who have existing cardiovascular disease or at elevated risk.”
The study received no commercial funding. Mr. Ayada and Dr. Sattar had no relevant conflicts of interest.
AT ILC 2022
Irritable bowel syndrome therapy removed from market (again)
Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.
The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.
The drug has been through a teeter totter of regulations since its inception.
When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.
Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.
Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.
“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.
Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.
A version of this article first appeared on Medscape.com.
Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.
The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.
The drug has been through a teeter totter of regulations since its inception.
When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.
Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.
Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.
“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.
Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.
A version of this article first appeared on Medscape.com.
Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.
The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.
The drug has been through a teeter totter of regulations since its inception.
When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.
Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.
Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.
“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.
Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.
A version of this article first appeared on Medscape.com.
FDA warning: Lymphoma drug heightens risk of death
The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.
Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.
However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.
“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.
More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).
Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.
Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.
A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.
This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”
As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.
“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.
The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.
A version of this article first appeared on Medscape.com
The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.
Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.
However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.
“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.
More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).
Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.
Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.
A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.
This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”
As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.
“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.
The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.
A version of this article first appeared on Medscape.com
The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.
Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.
However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.
“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.
More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).
Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.
Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.
A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.
This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”
As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.
“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.
The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.
A version of this article first appeared on Medscape.com