Pediatrics

Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.

“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”

Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.

“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”

Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).

Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.

Dr. Maria has held a number of professorial roles over his tenure, including Professor of Pediatrics, Neurology, and Neurosciences (with tenure), at the Medical University of South Carolina, Distinguished Chair and Professor of Pediatrics; Professor of Pediatrics, Neurology, and Neurosurgery (with tenure) at the Medical College of Georgia—Georgia Regents University, and currently serves as Professor of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia. He has chaired two departments of pediatrics and was founding director of the largest pediatric research institute in the Carolinas, the Charles P. Darby Children’s Research Institute.

Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.

“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”

Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.

“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”

Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).

Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.

Dr. Maria has held a number of professorial roles over his tenure, including Professor of Pediatrics, Neurology, and Neurosciences (with tenure), at the Medical University of South Carolina, Distinguished Chair and Professor of Pediatrics; Professor of Pediatrics, Neurology, and Neurosurgery (with tenure) at the Medical College of Georgia—Georgia Regents University, and currently serves as Professor of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia. He has chaired two departments of pediatrics and was founding director of the largest pediatric research institute in the Carolinas, the Charles P. Darby Children’s Research Institute.

Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.

“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”

Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.

“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”

Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).

Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.

Dr. Maria has held a number of professorial roles over his tenure, including Professor of Pediatrics, Neurology, and Neurosciences (with tenure), at the Medical University of South Carolina, Distinguished Chair and Professor of Pediatrics; Professor of Pediatrics, Neurology, and Neurosurgery (with tenure) at the Medical College of Georgia—Georgia Regents University, and currently serves as Professor of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia. He has chaired two departments of pediatrics and was founding director of the largest pediatric research institute in the Carolinas, the Charles P. Darby Children’s Research Institute.

The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.

Lori Farmer/MDedge News

In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.

All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.

Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.

Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.

Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.

The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.

AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.

SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.

The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.

Lori Farmer/MDedge News

In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.

All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.

Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.

Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.

Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.

The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.

AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.

SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.

The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.

Lori Farmer/MDedge News

In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.

All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.

Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.

Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.

Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.

The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.

AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.

SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.

“Breast Milk From Bottle May Not Be As Beneficial As Feeding Directly From The Breast, Researchers Say.” This was the headline on the AAP Daily Briefing that was sent to American Academy of Pediatrics members on Sept 25, 2018.

©Jaimie Duplass/Fotolia.com

I suspect that this finding doesn’t surprise you. I can imagine a dozen factors that could make bottled breast milk less advantageous for a baby than milk received directly from the mother’s breast. Antibodies might adhere to the glass surface. A few degrees above or below body temperature could interfere with gastric emptying. Or a temptation to focus on the level in the bottle and inadvertently overfeed could inflate the baby’s body mass index at 3 months, as was found in the study published online in the September 2018 issue of Pediatrics (“Infant Feeding and Weight Gain: Separating Breast Milk From Breastfeeding and Formula From Food”).

I agree that the title of the actual paper is rather dry; it’s a scientific research paper. But the distillation chosen by the folks at AAP Daily Briefing seems ill advised. They were not alone. CCN-Health chose “Breastfeeding better for babies’ weight gain than pumping, new study says” (Michael Nedelman, Sept. 24, 2018). HealthDay News headlined its story with “Milk straight from breast best for baby’s weight” (Sept. 24, 2018).

The articles themselves were well balanced and accurately described this research based on more than 2,500 Canadian mother-infant dyads. But not everyone – including mothers who are struggling with or considering breastfeeding – reads beyond the headlines. How many realize that “better for babies’ weight gain” means a slower weight gain? For the mother who has found that, for a variety of reasons, pumping is the only way she can provide her baby the benefits of breast milk, what these headlines suggest is another blow to her already fragile sense of self-worth.

This research article is excellent and should be read by all of us who counsel young families. It suggests that one of the contributors to our epidemic of childhood obesity may be that bottle-feeding discourages the infant’s own self-regulation skills. It should prompt us to ask every parent who is bottle-feeding his or her baby – regardless of what is in the bottle – exactly how they decide how much to put in the bottle and how long a feeding takes. Even if we are comfortable with the infant’s weight gain, we should caution parents to be more aware of the baby’s cues that he or she has had enough. Not every baby provides cues that are obvious, and parents may need our coaching in deciding how much to feed. This research paper also suggests that as long as breastfeeding was continued, introduction of solids as early as 5 months was not associated with an unhealthy BMI trajectory.

Unfortunately, the reporting of this research article is another example of the hazards of the explosive growth of the Internet. There really is no reason to keep the results of well-crafted research from the lay public, particularly if they are explained in common sense language. However, this places a burden of responsibility on the editors of websites to consider the damage that can be done by a poorly chosen headline.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

“Breast Milk From Bottle May Not Be As Beneficial As Feeding Directly From The Breast, Researchers Say.” This was the headline on the AAP Daily Briefing that was sent to American Academy of Pediatrics members on Sept 25, 2018.

©Jaimie Duplass/Fotolia.com

I suspect that this finding doesn’t surprise you. I can imagine a dozen factors that could make bottled breast milk less advantageous for a baby than milk received directly from the mother’s breast. Antibodies might adhere to the glass surface. A few degrees above or below body temperature could interfere with gastric emptying. Or a temptation to focus on the level in the bottle and inadvertently overfeed could inflate the baby’s body mass index at 3 months, as was found in the study published online in the September 2018 issue of Pediatrics (“Infant Feeding and Weight Gain: Separating Breast Milk From Breastfeeding and Formula From Food”).

I agree that the title of the actual paper is rather dry; it’s a scientific research paper. But the distillation chosen by the folks at AAP Daily Briefing seems ill advised. They were not alone. CCN-Health chose “Breastfeeding better for babies’ weight gain than pumping, new study says” (Michael Nedelman, Sept. 24, 2018). HealthDay News headlined its story with “Milk straight from breast best for baby’s weight” (Sept. 24, 2018).

The articles themselves were well balanced and accurately described this research based on more than 2,500 Canadian mother-infant dyads. But not everyone – including mothers who are struggling with or considering breastfeeding – reads beyond the headlines. How many realize that “better for babies’ weight gain” means a slower weight gain? For the mother who has found that, for a variety of reasons, pumping is the only way she can provide her baby the benefits of breast milk, what these headlines suggest is another blow to her already fragile sense of self-worth.

This research article is excellent and should be read by all of us who counsel young families. It suggests that one of the contributors to our epidemic of childhood obesity may be that bottle-feeding discourages the infant’s own self-regulation skills. It should prompt us to ask every parent who is bottle-feeding his or her baby – regardless of what is in the bottle – exactly how they decide how much to put in the bottle and how long a feeding takes. Even if we are comfortable with the infant’s weight gain, we should caution parents to be more aware of the baby’s cues that he or she has had enough. Not every baby provides cues that are obvious, and parents may need our coaching in deciding how much to feed. This research paper also suggests that as long as breastfeeding was continued, introduction of solids as early as 5 months was not associated with an unhealthy BMI trajectory.

Unfortunately, the reporting of this research article is another example of the hazards of the explosive growth of the Internet. There really is no reason to keep the results of well-crafted research from the lay public, particularly if they are explained in common sense language. However, this places a burden of responsibility on the editors of websites to consider the damage that can be done by a poorly chosen headline.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

“Breast Milk From Bottle May Not Be As Beneficial As Feeding Directly From The Breast, Researchers Say.” This was the headline on the AAP Daily Briefing that was sent to American Academy of Pediatrics members on Sept 25, 2018.

©Jaimie Duplass/Fotolia.com

I suspect that this finding doesn’t surprise you. I can imagine a dozen factors that could make bottled breast milk less advantageous for a baby than milk received directly from the mother’s breast. Antibodies might adhere to the glass surface. A few degrees above or below body temperature could interfere with gastric emptying. Or a temptation to focus on the level in the bottle and inadvertently overfeed could inflate the baby’s body mass index at 3 months, as was found in the study published online in the September 2018 issue of Pediatrics (“Infant Feeding and Weight Gain: Separating Breast Milk From Breastfeeding and Formula From Food”).

I agree that the title of the actual paper is rather dry; it’s a scientific research paper. But the distillation chosen by the folks at AAP Daily Briefing seems ill advised. They were not alone. CCN-Health chose “Breastfeeding better for babies’ weight gain than pumping, new study says” (Michael Nedelman, Sept. 24, 2018). HealthDay News headlined its story with “Milk straight from breast best for baby’s weight” (Sept. 24, 2018).

The articles themselves were well balanced and accurately described this research based on more than 2,500 Canadian mother-infant dyads. But not everyone – including mothers who are struggling with or considering breastfeeding – reads beyond the headlines. How many realize that “better for babies’ weight gain” means a slower weight gain? For the mother who has found that, for a variety of reasons, pumping is the only way she can provide her baby the benefits of breast milk, what these headlines suggest is another blow to her already fragile sense of self-worth.

This research article is excellent and should be read by all of us who counsel young families. It suggests that one of the contributors to our epidemic of childhood obesity may be that bottle-feeding discourages the infant’s own self-regulation skills. It should prompt us to ask every parent who is bottle-feeding his or her baby – regardless of what is in the bottle – exactly how they decide how much to put in the bottle and how long a feeding takes. Even if we are comfortable with the infant’s weight gain, we should caution parents to be more aware of the baby’s cues that he or she has had enough. Not every baby provides cues that are obvious, and parents may need our coaching in deciding how much to feed. This research paper also suggests that as long as breastfeeding was continued, introduction of solids as early as 5 months was not associated with an unhealthy BMI trajectory.

Unfortunately, the reporting of this research article is another example of the hazards of the explosive growth of the Internet. There really is no reason to keep the results of well-crafted research from the lay public, particularly if they are explained in common sense language. However, this places a burden of responsibility on the editors of websites to consider the damage that can be done by a poorly chosen headline.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

The Food and Drug Administration has approved sarecycline (Seysara) for the treatment of moderate to severe acne vulgaris for people aged 9 years and older, according to a press release from Paratek, the drug’s manufacturer.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval is based on results from two phase 3 clinical trials (NCT02320149 and NCT02322866), in which patients received either sarecycline at 1.5 mg/kg per day or placebo for 12 weeks. Patients who received sarecycline were significantly more likely to reach the primary endpoint of improved acne severity based on absolute change in facial lesion counts and percentage of participants with Investigator Global Assessment success.

Common adverse events reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The discontinuation rate due to adverse events among sarecycline-treated patients in both studies combined was 1.4%.

Sarecycline is an oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties, and is approved for once-daily use, according to Paratek. Seysara will be marketed in the United States by Almirall SA.
 

lfranki@mdedge.com

The Food and Drug Administration has approved sarecycline (Seysara) for the treatment of moderate to severe acne vulgaris for people aged 9 years and older, according to a press release from Paratek, the drug’s manufacturer.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval is based on results from two phase 3 clinical trials (NCT02320149 and NCT02322866), in which patients received either sarecycline at 1.5 mg/kg per day or placebo for 12 weeks. Patients who received sarecycline were significantly more likely to reach the primary endpoint of improved acne severity based on absolute change in facial lesion counts and percentage of participants with Investigator Global Assessment success.

Common adverse events reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The discontinuation rate due to adverse events among sarecycline-treated patients in both studies combined was 1.4%.

Sarecycline is an oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties, and is approved for once-daily use, according to Paratek. Seysara will be marketed in the United States by Almirall SA.
 

lfranki@mdedge.com

The Food and Drug Administration has approved sarecycline (Seysara) for the treatment of moderate to severe acne vulgaris for people aged 9 years and older, according to a press release from Paratek, the drug’s manufacturer.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval is based on results from two phase 3 clinical trials (NCT02320149 and NCT02322866), in which patients received either sarecycline at 1.5 mg/kg per day or placebo for 12 weeks. Patients who received sarecycline were significantly more likely to reach the primary endpoint of improved acne severity based on absolute change in facial lesion counts and percentage of participants with Investigator Global Assessment success.

Common adverse events reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The discontinuation rate due to adverse events among sarecycline-treated patients in both studies combined was 1.4%.

Sarecycline is an oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties, and is approved for once-daily use, according to Paratek. Seysara will be marketed in the United States by Almirall SA.
 

lfranki@mdedge.com

CHICAGO – It’s best to aim for an office blood pressure between the 50th and 75th percentiles in children with chronic kidney disease (CKD), according to a review of 690 pediatric patients in the Chronic Kidney Disease in Children Cohort Study.

M. Alexander Otto/MDedge News

Hypertensive children with CKD were less likely to progress to dialysis or kidney transplant or have a 30% decline in estimated glomerular filtration rate (eGFR) when kept in that range, compared with children above or below it. “Achieved office [blood pressure] between the 50th and 75th percentiles appeared to offer the greatest protection against CKD progression in this cohort,” said investigators led by Joseph Flynn, MD, chief of the nephrology division at Seattle Children’s Hospital.

“We needed to have some [evidence] on what to do based on office blood pressure,” something that had been missing in the literature until now. “I think this is going to be very impactful on the care of children with CKD. Right now, the guidelines say to keep” pressures below the 90th percentile for age and height. “The guidelines [might] need to be changed,” said Dr. Flynn, also the lead author of the American Academy of Pediatrics 2017 blood pressure guidelines for children and adolescents (Pediatrics. 2017 Aug 21. doi: 10.1542/peds.2017-1904).

There was “no evidence to go below the 50th percentile; the 50th-75th seems to be the sweet spot for office blood pressure,” he said at the joint scientific sessions of the AHA Council on Hypertension, the AHA Council on Kidney in Cardiovascular Disease, and the American Society of Hypertension.

The 476 children with nonglomerular CKD actually did worse when their blood pressures were pushed below the 50th percentile, perhaps because of renal hypoperfusion. The 476 children with glomerular CKD did no better or worse below the 50th percentile than they did in the 50th-75th.

Children at or above the 90th percentile had the highest risk of progression, with about 80% needing renal replacement therapy or having a 30% drop in eGFR at 5-8 years of follow-up. Compared with children with glomerular CKD who were in the 90th percentile, the risk hazard (RH) for progression over 3 years was 0.10-0.30 (P less than 0.001) among those children with glomerular CKD who were kept in the 50th-75th percentile. Compared with children with nonglomerular CKD who were in the 90th percentile, the RH over 8 years among those in the 50th-75th percentile was 0.48 (P less than 0.001). Risk of progression in both glomerular and nonglomerular patients in the sweet spot was less than 50% at 5-8 years of follow-up.

When glomerular and nonglomerular patients were considered together, those with pressures below the 50th percentile were less likely to progress than children with pressures between the 75th and 90th, but they were more likely to progress than the 50th-75th percentile group.

Research nurses took three blood pressures by auscultation a minute apart after 5 minutes of rest. Most of the children were treated at first with angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers, per recommendations. Dihydropyridine calcium channel blockers (for example, amlodipine and nifedipine) were most likely to be used next.

It was a curious finding because dihydropyridines have been show to worsen proteinuria in adults with CKD. The team is investigating to see whether they have the same effect in children. If so, “we’ll be able to tell people to stop using them,” Dr. Flynn said.

The median age in the study was 11.3 years, and almost two-thirds of the subjects were boys. The median duration of disease was 8 years. Some children in the ongoing cohort have been followed for almost 10 years. The analysis is based on children who entered the cohort with hypertension or developed it after enrollment.

The nationwide Chronic Kidney Disease in Children Cohort Study is funded by the National Institutes of Health. Dr. Flynn is an advisor for Ultragenyx and Silvergate Pharmaceuticals.

aotto@mdedge.com

CHICAGO – It’s best to aim for an office blood pressure between the 50th and 75th percentiles in children with chronic kidney disease (CKD), according to a review of 690 pediatric patients in the Chronic Kidney Disease in Children Cohort Study.

M. Alexander Otto/MDedge News

Hypertensive children with CKD were less likely to progress to dialysis or kidney transplant or have a 30% decline in estimated glomerular filtration rate (eGFR) when kept in that range, compared with children above or below it. “Achieved office [blood pressure] between the 50th and 75th percentiles appeared to offer the greatest protection against CKD progression in this cohort,” said investigators led by Joseph Flynn, MD, chief of the nephrology division at Seattle Children’s Hospital.

“We needed to have some [evidence] on what to do based on office blood pressure,” something that had been missing in the literature until now. “I think this is going to be very impactful on the care of children with CKD. Right now, the guidelines say to keep” pressures below the 90th percentile for age and height. “The guidelines [might] need to be changed,” said Dr. Flynn, also the lead author of the American Academy of Pediatrics 2017 blood pressure guidelines for children and adolescents (Pediatrics. 2017 Aug 21. doi: 10.1542/peds.2017-1904).

There was “no evidence to go below the 50th percentile; the 50th-75th seems to be the sweet spot for office blood pressure,” he said at the joint scientific sessions of the AHA Council on Hypertension, the AHA Council on Kidney in Cardiovascular Disease, and the American Society of Hypertension.

The 476 children with nonglomerular CKD actually did worse when their blood pressures were pushed below the 50th percentile, perhaps because of renal hypoperfusion. The 476 children with glomerular CKD did no better or worse below the 50th percentile than they did in the 50th-75th.

Children at or above the 90th percentile had the highest risk of progression, with about 80% needing renal replacement therapy or having a 30% drop in eGFR at 5-8 years of follow-up. Compared with children with glomerular CKD who were in the 90th percentile, the risk hazard (RH) for progression over 3 years was 0.10-0.30 (P less than 0.001) among those children with glomerular CKD who were kept in the 50th-75th percentile. Compared with children with nonglomerular CKD who were in the 90th percentile, the RH over 8 years among those in the 50th-75th percentile was 0.48 (P less than 0.001). Risk of progression in both glomerular and nonglomerular patients in the sweet spot was less than 50% at 5-8 years of follow-up.

When glomerular and nonglomerular patients were considered together, those with pressures below the 50th percentile were less likely to progress than children with pressures between the 75th and 90th, but they were more likely to progress than the 50th-75th percentile group.

Research nurses took three blood pressures by auscultation a minute apart after 5 minutes of rest. Most of the children were treated at first with angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers, per recommendations. Dihydropyridine calcium channel blockers (for example, amlodipine and nifedipine) were most likely to be used next.

It was a curious finding because dihydropyridines have been show to worsen proteinuria in adults with CKD. The team is investigating to see whether they have the same effect in children. If so, “we’ll be able to tell people to stop using them,” Dr. Flynn said.

The median age in the study was 11.3 years, and almost two-thirds of the subjects were boys. The median duration of disease was 8 years. Some children in the ongoing cohort have been followed for almost 10 years. The analysis is based on children who entered the cohort with hypertension or developed it after enrollment.

The nationwide Chronic Kidney Disease in Children Cohort Study is funded by the National Institutes of Health. Dr. Flynn is an advisor for Ultragenyx and Silvergate Pharmaceuticals.

aotto@mdedge.com

CHICAGO – It’s best to aim for an office blood pressure between the 50th and 75th percentiles in children with chronic kidney disease (CKD), according to a review of 690 pediatric patients in the Chronic Kidney Disease in Children Cohort Study.

M. Alexander Otto/MDedge News

Hypertensive children with CKD were less likely to progress to dialysis or kidney transplant or have a 30% decline in estimated glomerular filtration rate (eGFR) when kept in that range, compared with children above or below it. “Achieved office [blood pressure] between the 50th and 75th percentiles appeared to offer the greatest protection against CKD progression in this cohort,” said investigators led by Joseph Flynn, MD, chief of the nephrology division at Seattle Children’s Hospital.

“We needed to have some [evidence] on what to do based on office blood pressure,” something that had been missing in the literature until now. “I think this is going to be very impactful on the care of children with CKD. Right now, the guidelines say to keep” pressures below the 90th percentile for age and height. “The guidelines [might] need to be changed,” said Dr. Flynn, also the lead author of the American Academy of Pediatrics 2017 blood pressure guidelines for children and adolescents (Pediatrics. 2017 Aug 21. doi: 10.1542/peds.2017-1904).

There was “no evidence to go below the 50th percentile; the 50th-75th seems to be the sweet spot for office blood pressure,” he said at the joint scientific sessions of the AHA Council on Hypertension, the AHA Council on Kidney in Cardiovascular Disease, and the American Society of Hypertension.

The 476 children with nonglomerular CKD actually did worse when their blood pressures were pushed below the 50th percentile, perhaps because of renal hypoperfusion. The 476 children with glomerular CKD did no better or worse below the 50th percentile than they did in the 50th-75th.

Children at or above the 90th percentile had the highest risk of progression, with about 80% needing renal replacement therapy or having a 30% drop in eGFR at 5-8 years of follow-up. Compared with children with glomerular CKD who were in the 90th percentile, the risk hazard (RH) for progression over 3 years was 0.10-0.30 (P less than 0.001) among those children with glomerular CKD who were kept in the 50th-75th percentile. Compared with children with nonglomerular CKD who were in the 90th percentile, the RH over 8 years among those in the 50th-75th percentile was 0.48 (P less than 0.001). Risk of progression in both glomerular and nonglomerular patients in the sweet spot was less than 50% at 5-8 years of follow-up.

When glomerular and nonglomerular patients were considered together, those with pressures below the 50th percentile were less likely to progress than children with pressures between the 75th and 90th, but they were more likely to progress than the 50th-75th percentile group.

Research nurses took three blood pressures by auscultation a minute apart after 5 minutes of rest. Most of the children were treated at first with angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers, per recommendations. Dihydropyridine calcium channel blockers (for example, amlodipine and nifedipine) were most likely to be used next.

It was a curious finding because dihydropyridines have been show to worsen proteinuria in adults with CKD. The team is investigating to see whether they have the same effect in children. If so, “we’ll be able to tell people to stop using them,” Dr. Flynn said.

The median age in the study was 11.3 years, and almost two-thirds of the subjects were boys. The median duration of disease was 8 years. Some children in the ongoing cohort have been followed for almost 10 years. The analysis is based on children who entered the cohort with hypertension or developed it after enrollment.

The nationwide Chronic Kidney Disease in Children Cohort Study is funded by the National Institutes of Health. Dr. Flynn is an advisor for Ultragenyx and Silvergate Pharmaceuticals.

aotto@mdedge.com

There is no doubt that some high school students will try to get high. However, the ways they’re doing it might be changing.

skydie/ThinkStock

A survey of more than 3,000 10th-graders from 10 high schools in Los Angeles showed that, while traditional combustible marijuana is still the most popular method, kids are turning to edible and vaporized weed, according to a study published in JAMA Network Open Sept. 28.

Because of L.A.’s size and diversity, the researchers said, the patterns of cannabis use they tracked provide insights about “a wide cross-section” of American teens. They found that 62% of students who had ever tried marijuana had used multiple kinds and around 8% tried all three forms.

Those findings were consistent with the impressions of Andrew G., a 15-year-old from the Washington metropolitan area. (Kaiser Health News is not fully identifying him because he is a minor.) While he doesn’t use marijuana, he guessed that more than half of his peers have tried it. He also knows people who have used it in all three forms.

“I feel like, because it’s being incorporated in new ways – edibles, vaping – the stigma has been broken,” he said.

This attitude of wider acceptance and greater access worries researchers. “We are concerned about the developing teen brain, the potential effects on cognitive development, mood and exposure to cannabinoids and chemicals in these various products,” said Adam Leventhal, PhD, an author on the study and a professor at the University of Southern California, Los Angeles.

Dr. Leventhal called this “polyproduct use” alarming for a number of reasons.

A major one is that the body processes these forms of cannabis differently. Smoking or vaping likely has a more immediate effect, while eating it takes a longer time for the body to process. Teens might not realize how much they’re ingesting, Dr. Leventhal said.

Also, “these novel products could be drawing in youth who could be otherwise be deterred,” he added, referring to a range of commercially available cannabinoid-infused products such as gummy bears and energy drinks.

If kids are consuming many different products, he said, it increases the potential risk for addiction.

“It’s a parallel issue. We definitely do see teens who use more different forms of nicotine and tobacco products are at more risk of addiction,” Dr. Leventhal said.

The study was a cross-sectional survey of 10th-graders in the Los Angeles area. It was conducted during Jan. 2, 2015–Oct. 6, 2015. The location and timing of the survey was important, noted the researchers, because California legalized medical cannabis in 1996. In 2018, it became one of nine states to allow the sale for recreational use.

The findings, Dr. Leventhal said, could be an early warning for a trend that will only increase as more states legalize marijuana. Specifically, cannabis products appear to be gaining ground among teens, compared with other substances.

Teen alcohol and nicotine use, for example, has been on the decline for years, according to Monitoring the Future, a multidecade survey conducted by the University of Michigan, Ann Arbor.

“It’s really a public health and policy success story,” Richard Miech, PhD, the survey’s principal investigator, wrote in an email. “In contrast, marijuana use hasn’t declined much at all in the past two decades.” He was not involved in the JAMA study.

Dr. Leventhal also highlighted a socioeconomic element in the findings.

Traditionally, kids who were in a higher socioeconomic bracket were at a lower risk of using marijuana, he said. That’s still true for traditional and edible cannabis, but wealthier kids were more likely to use vaporized weed, according to the study.

Leventhal thinks the popularity of vaping is pulling more kids and teenagers into marijuana use. It removes some of the common barriers that keeps kids away from drugs: There’s no telltale smell that would alert parents, no harshness in their lungs, and a perception that it’s safer than traditional smoke.

“The same vaporizer could be used, teens can load in a liquid on one day with nicotine and the next day a liquid that has THC or another cannabinoid,” Dr. Leventhal said.

And then it might be harder for parents or teachers to detect kids’ drug use.

Getting caught with a bag of marijuana plants could immediately get a kid in trouble. But if a parent finds a vape that looks like a normal e-cigarette or a package of gummy bears laced with THC, they might not realize what they’re seeing.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

There is no doubt that some high school students will try to get high. However, the ways they’re doing it might be changing.

skydie/ThinkStock

A survey of more than 3,000 10th-graders from 10 high schools in Los Angeles showed that, while traditional combustible marijuana is still the most popular method, kids are turning to edible and vaporized weed, according to a study published in JAMA Network Open Sept. 28.

Because of L.A.’s size and diversity, the researchers said, the patterns of cannabis use they tracked provide insights about “a wide cross-section” of American teens. They found that 62% of students who had ever tried marijuana had used multiple kinds and around 8% tried all three forms.

Those findings were consistent with the impressions of Andrew G., a 15-year-old from the Washington metropolitan area. (Kaiser Health News is not fully identifying him because he is a minor.) While he doesn’t use marijuana, he guessed that more than half of his peers have tried it. He also knows people who have used it in all three forms.

“I feel like, because it’s being incorporated in new ways – edibles, vaping – the stigma has been broken,” he said.

This attitude of wider acceptance and greater access worries researchers. “We are concerned about the developing teen brain, the potential effects on cognitive development, mood and exposure to cannabinoids and chemicals in these various products,” said Adam Leventhal, PhD, an author on the study and a professor at the University of Southern California, Los Angeles.

Dr. Leventhal called this “polyproduct use” alarming for a number of reasons.

A major one is that the body processes these forms of cannabis differently. Smoking or vaping likely has a more immediate effect, while eating it takes a longer time for the body to process. Teens might not realize how much they’re ingesting, Dr. Leventhal said.

Also, “these novel products could be drawing in youth who could be otherwise be deterred,” he added, referring to a range of commercially available cannabinoid-infused products such as gummy bears and energy drinks.

If kids are consuming many different products, he said, it increases the potential risk for addiction.

“It’s a parallel issue. We definitely do see teens who use more different forms of nicotine and tobacco products are at more risk of addiction,” Dr. Leventhal said.

The study was a cross-sectional survey of 10th-graders in the Los Angeles area. It was conducted during Jan. 2, 2015–Oct. 6, 2015. The location and timing of the survey was important, noted the researchers, because California legalized medical cannabis in 1996. In 2018, it became one of nine states to allow the sale for recreational use.

The findings, Dr. Leventhal said, could be an early warning for a trend that will only increase as more states legalize marijuana. Specifically, cannabis products appear to be gaining ground among teens, compared with other substances.

Teen alcohol and nicotine use, for example, has been on the decline for years, according to Monitoring the Future, a multidecade survey conducted by the University of Michigan, Ann Arbor.

“It’s really a public health and policy success story,” Richard Miech, PhD, the survey’s principal investigator, wrote in an email. “In contrast, marijuana use hasn’t declined much at all in the past two decades.” He was not involved in the JAMA study.

Dr. Leventhal also highlighted a socioeconomic element in the findings.

Traditionally, kids who were in a higher socioeconomic bracket were at a lower risk of using marijuana, he said. That’s still true for traditional and edible cannabis, but wealthier kids were more likely to use vaporized weed, according to the study.

Leventhal thinks the popularity of vaping is pulling more kids and teenagers into marijuana use. It removes some of the common barriers that keeps kids away from drugs: There’s no telltale smell that would alert parents, no harshness in their lungs, and a perception that it’s safer than traditional smoke.

“The same vaporizer could be used, teens can load in a liquid on one day with nicotine and the next day a liquid that has THC or another cannabinoid,” Dr. Leventhal said.

And then it might be harder for parents or teachers to detect kids’ drug use.

Getting caught with a bag of marijuana plants could immediately get a kid in trouble. But if a parent finds a vape that looks like a normal e-cigarette or a package of gummy bears laced with THC, they might not realize what they’re seeing.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

There is no doubt that some high school students will try to get high. However, the ways they’re doing it might be changing.

skydie/ThinkStock

A survey of more than 3,000 10th-graders from 10 high schools in Los Angeles showed that, while traditional combustible marijuana is still the most popular method, kids are turning to edible and vaporized weed, according to a study published in JAMA Network Open Sept. 28.

Because of L.A.’s size and diversity, the researchers said, the patterns of cannabis use they tracked provide insights about “a wide cross-section” of American teens. They found that 62% of students who had ever tried marijuana had used multiple kinds and around 8% tried all three forms.

Those findings were consistent with the impressions of Andrew G., a 15-year-old from the Washington metropolitan area. (Kaiser Health News is not fully identifying him because he is a minor.) While he doesn’t use marijuana, he guessed that more than half of his peers have tried it. He also knows people who have used it in all three forms.

“I feel like, because it’s being incorporated in new ways – edibles, vaping – the stigma has been broken,” he said.

This attitude of wider acceptance and greater access worries researchers. “We are concerned about the developing teen brain, the potential effects on cognitive development, mood and exposure to cannabinoids and chemicals in these various products,” said Adam Leventhal, PhD, an author on the study and a professor at the University of Southern California, Los Angeles.

Dr. Leventhal called this “polyproduct use” alarming for a number of reasons.

A major one is that the body processes these forms of cannabis differently. Smoking or vaping likely has a more immediate effect, while eating it takes a longer time for the body to process. Teens might not realize how much they’re ingesting, Dr. Leventhal said.

Also, “these novel products could be drawing in youth who could be otherwise be deterred,” he added, referring to a range of commercially available cannabinoid-infused products such as gummy bears and energy drinks.

If kids are consuming many different products, he said, it increases the potential risk for addiction.

“It’s a parallel issue. We definitely do see teens who use more different forms of nicotine and tobacco products are at more risk of addiction,” Dr. Leventhal said.

The study was a cross-sectional survey of 10th-graders in the Los Angeles area. It was conducted during Jan. 2, 2015–Oct. 6, 2015. The location and timing of the survey was important, noted the researchers, because California legalized medical cannabis in 1996. In 2018, it became one of nine states to allow the sale for recreational use.

The findings, Dr. Leventhal said, could be an early warning for a trend that will only increase as more states legalize marijuana. Specifically, cannabis products appear to be gaining ground among teens, compared with other substances.

Teen alcohol and nicotine use, for example, has been on the decline for years, according to Monitoring the Future, a multidecade survey conducted by the University of Michigan, Ann Arbor.

“It’s really a public health and policy success story,” Richard Miech, PhD, the survey’s principal investigator, wrote in an email. “In contrast, marijuana use hasn’t declined much at all in the past two decades.” He was not involved in the JAMA study.

Dr. Leventhal also highlighted a socioeconomic element in the findings.

Traditionally, kids who were in a higher socioeconomic bracket were at a lower risk of using marijuana, he said. That’s still true for traditional and edible cannabis, but wealthier kids were more likely to use vaporized weed, according to the study.

Leventhal thinks the popularity of vaping is pulling more kids and teenagers into marijuana use. It removes some of the common barriers that keeps kids away from drugs: There’s no telltale smell that would alert parents, no harshness in their lungs, and a perception that it’s safer than traditional smoke.

“The same vaporizer could be used, teens can load in a liquid on one day with nicotine and the next day a liquid that has THC or another cannabinoid,” Dr. Leventhal said.

And then it might be harder for parents or teachers to detect kids’ drug use.

Getting caught with a bag of marijuana plants could immediately get a kid in trouble. But if a parent finds a vape that looks like a normal e-cigarette or a package of gummy bears laced with THC, they might not realize what they’re seeing.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Researchers found a lower rate of pediatric fever after applying a standard definition of fever across three different clinical trials of pediatric patients receiving influenza vaccinations, according to research published in the Pediatric Infectious Disease Journal.

Yangna/Thinkstock

Investigators in future studies must adopt a standardized definition of pediatric fever after an influenza vaccination. “Our study demonstrates the variability in results which occur due to minor differences in the definition of fever, methods of analysis and reporting of results,” Jean Li-Kim-Moy, MBBS, of the University of Sydney, and colleagues wrote.

Dr. Li-Kim-Moy and colleagues analyzed pediatric datasets from three different clinical trials using trivalent influenza vaccine (TIV); the primary trial included 3,317 children aged 6-35 months who were randomized to receive Fluarix at 0.25 mL or 0.5 mL, or receive 0.25 mL of Fluzone. The other two trials studied children receiving TIV between 6 months–17 years and 3-17 years. The researchers also performed a multivariable regression analysis to determine the relationship between immunogenicity, antipyretic use, and postvaccination fever.

The primary study initially reported the fever rate 0 days–3 days after vaccination was between 6% and 7%. After reporting the rate of fever separately for each dose and changing the criteria to “defining fever as greater than or equal to 38.0°C by any route of measurement” for the primary study, the researchers found a rate of any-cause fever was 3%-4% for the first dose and 4%-5% for the second dose. The rate of vaccine-related fever in the primary study was 3% for the first dose and 3%-4% for the second dose, with researchers noting vaccine-related fever occurred significantly earlier compared with any-cause fever (mean 1 days vs. 2 days after vaccination; P equals .04).

Impact of fever, antipyretics

The researchers also performed a pooled immunogenicity analysis of 5,902 children from all three trials and found a strong association between fever after vaccination and increased geometric mean titer (GMT) ratios (1.21-1.39; P less than or equal to .01) and an association between antipyretic use and reduced GMT ratios (0.80-0.87; P less than .0006).

“Our pooled analysis of the three trials demonstrated highly significant associations, for all strains, between postvaccination fever and up to 39% higher GMT; this may suggest a close role between fever and the body’s immunologic response to the influenza antigens within the vaccine. Similarly, strong evidence of associations in the opposite direction was found between postvaccination antipyretic use (days 0-3), adjusting for all other factors including fever, and decreased immunogenicity against all vaccine strains in children,” Dr. Li-Kim-Moy and colleagues said.

Antipyretic use was common in the primary study, occurring in one in six of the children, they said. These findings of “significant associations between fever and increased vaccine immunogenicity, and between antipyretic use and reduced immunogenicity in children after influenza vaccination” suggest the need for further study, especially because parents often give antipyretics if their children are febrile after vaccinations.

“There is uncertainty whether our findings, and those of others, on immunogenicity translate into clinically significant effects,” they wrote. “However, the fact that influenza vaccine, unlike many routine childhood vaccines, is only moderately protective may mean that modest reductions in antibody response are more likely to correlate to less protection.”

Dr. Wood reported receiving a fellowship from the National Health and Medical Research Council (NHMRC) and being an investigator for GlaxoSmithKline trials. Dr. Booy reported being an advisor for influenza vaccine manufacturing, an advisory board member, on the speaker’s bureau, and a researcher of vaccines for several manufacturers. The other authors reported no relevant conflicts of interest.

SOURCE: Li-Kim-Moy J et al. Pediatr Infect Dis J. 2018 Oct;37(10):971-5.

Researchers found a lower rate of pediatric fever after applying a standard definition of fever across three different clinical trials of pediatric patients receiving influenza vaccinations, according to research published in the Pediatric Infectious Disease Journal.

Yangna/Thinkstock

Investigators in future studies must adopt a standardized definition of pediatric fever after an influenza vaccination. “Our study demonstrates the variability in results which occur due to minor differences in the definition of fever, methods of analysis and reporting of results,” Jean Li-Kim-Moy, MBBS, of the University of Sydney, and colleagues wrote.

Dr. Li-Kim-Moy and colleagues analyzed pediatric datasets from three different clinical trials using trivalent influenza vaccine (TIV); the primary trial included 3,317 children aged 6-35 months who were randomized to receive Fluarix at 0.25 mL or 0.5 mL, or receive 0.25 mL of Fluzone. The other two trials studied children receiving TIV between 6 months–17 years and 3-17 years. The researchers also performed a multivariable regression analysis to determine the relationship between immunogenicity, antipyretic use, and postvaccination fever.

The primary study initially reported the fever rate 0 days–3 days after vaccination was between 6% and 7%. After reporting the rate of fever separately for each dose and changing the criteria to “defining fever as greater than or equal to 38.0°C by any route of measurement” for the primary study, the researchers found a rate of any-cause fever was 3%-4% for the first dose and 4%-5% for the second dose. The rate of vaccine-related fever in the primary study was 3% for the first dose and 3%-4% for the second dose, with researchers noting vaccine-related fever occurred significantly earlier compared with any-cause fever (mean 1 days vs. 2 days after vaccination; P equals .04).

Impact of fever, antipyretics

The researchers also performed a pooled immunogenicity analysis of 5,902 children from all three trials and found a strong association between fever after vaccination and increased geometric mean titer (GMT) ratios (1.21-1.39; P less than or equal to .01) and an association between antipyretic use and reduced GMT ratios (0.80-0.87; P less than .0006).

“Our pooled analysis of the three trials demonstrated highly significant associations, for all strains, between postvaccination fever and up to 39% higher GMT; this may suggest a close role between fever and the body’s immunologic response to the influenza antigens within the vaccine. Similarly, strong evidence of associations in the opposite direction was found between postvaccination antipyretic use (days 0-3), adjusting for all other factors including fever, and decreased immunogenicity against all vaccine strains in children,” Dr. Li-Kim-Moy and colleagues said.

Antipyretic use was common in the primary study, occurring in one in six of the children, they said. These findings of “significant associations between fever and increased vaccine immunogenicity, and between antipyretic use and reduced immunogenicity in children after influenza vaccination” suggest the need for further study, especially because parents often give antipyretics if their children are febrile after vaccinations.

“There is uncertainty whether our findings, and those of others, on immunogenicity translate into clinically significant effects,” they wrote. “However, the fact that influenza vaccine, unlike many routine childhood vaccines, is only moderately protective may mean that modest reductions in antibody response are more likely to correlate to less protection.”

Dr. Wood reported receiving a fellowship from the National Health and Medical Research Council (NHMRC) and being an investigator for GlaxoSmithKline trials. Dr. Booy reported being an advisor for influenza vaccine manufacturing, an advisory board member, on the speaker’s bureau, and a researcher of vaccines for several manufacturers. The other authors reported no relevant conflicts of interest.

SOURCE: Li-Kim-Moy J et al. Pediatr Infect Dis J. 2018 Oct;37(10):971-5.

Researchers found a lower rate of pediatric fever after applying a standard definition of fever across three different clinical trials of pediatric patients receiving influenza vaccinations, according to research published in the Pediatric Infectious Disease Journal.

Yangna/Thinkstock

Investigators in future studies must adopt a standardized definition of pediatric fever after an influenza vaccination. “Our study demonstrates the variability in results which occur due to minor differences in the definition of fever, methods of analysis and reporting of results,” Jean Li-Kim-Moy, MBBS, of the University of Sydney, and colleagues wrote.

Dr. Li-Kim-Moy and colleagues analyzed pediatric datasets from three different clinical trials using trivalent influenza vaccine (TIV); the primary trial included 3,317 children aged 6-35 months who were randomized to receive Fluarix at 0.25 mL or 0.5 mL, or receive 0.25 mL of Fluzone. The other two trials studied children receiving TIV between 6 months–17 years and 3-17 years. The researchers also performed a multivariable regression analysis to determine the relationship between immunogenicity, antipyretic use, and postvaccination fever.

The primary study initially reported the fever rate 0 days–3 days after vaccination was between 6% and 7%. After reporting the rate of fever separately for each dose and changing the criteria to “defining fever as greater than or equal to 38.0°C by any route of measurement” for the primary study, the researchers found a rate of any-cause fever was 3%-4% for the first dose and 4%-5% for the second dose. The rate of vaccine-related fever in the primary study was 3% for the first dose and 3%-4% for the second dose, with researchers noting vaccine-related fever occurred significantly earlier compared with any-cause fever (mean 1 days vs. 2 days after vaccination; P equals .04).

Impact of fever, antipyretics

The researchers also performed a pooled immunogenicity analysis of 5,902 children from all three trials and found a strong association between fever after vaccination and increased geometric mean titer (GMT) ratios (1.21-1.39; P less than or equal to .01) and an association between antipyretic use and reduced GMT ratios (0.80-0.87; P less than .0006).

“Our pooled analysis of the three trials demonstrated highly significant associations, for all strains, between postvaccination fever and up to 39% higher GMT; this may suggest a close role between fever and the body’s immunologic response to the influenza antigens within the vaccine. Similarly, strong evidence of associations in the opposite direction was found between postvaccination antipyretic use (days 0-3), adjusting for all other factors including fever, and decreased immunogenicity against all vaccine strains in children,” Dr. Li-Kim-Moy and colleagues said.

Antipyretic use was common in the primary study, occurring in one in six of the children, they said. These findings of “significant associations between fever and increased vaccine immunogenicity, and between antipyretic use and reduced immunogenicity in children after influenza vaccination” suggest the need for further study, especially because parents often give antipyretics if their children are febrile after vaccinations.

“There is uncertainty whether our findings, and those of others, on immunogenicity translate into clinically significant effects,” they wrote. “However, the fact that influenza vaccine, unlike many routine childhood vaccines, is only moderately protective may mean that modest reductions in antibody response are more likely to correlate to less protection.”

Dr. Wood reported receiving a fellowship from the National Health and Medical Research Council (NHMRC) and being an investigator for GlaxoSmithKline trials. Dr. Booy reported being an advisor for influenza vaccine manufacturing, an advisory board member, on the speaker’s bureau, and a researcher of vaccines for several manufacturers. The other authors reported no relevant conflicts of interest.

SOURCE: Li-Kim-Moy J et al. Pediatr Infect Dis J. 2018 Oct;37(10):971-5.

Children with elevated scores on the Child Behavior Checklist (CBCL) anxiety/depression scale are at a higher risk of developing major depression and anxiety disorders in later adolescent or adult life, according to research published in the Journal of Pediatrics.

KatarzynaBialasiewicz/Thinkstock

“If confirmed, this observation could have very significant clinical and public health implications in the identification of children at the highest risk for the development of major depressive disorder,” Mai Uchida, MD, of the department of psychiatry at Massachusetts General Hospital in Boston, and colleagues wrote. “Early identification is the first step toward effectively allocating limited societal resources to help prevent illness progression and its associated impairments in children most in need.”

Dr. Uchida and her colleagues analyzed a sample of 537 children aged 6-17 years from two longitudinal studies of children and their parents with and without ADHD, excluding the ADHD probands in their analysis. Parents answered the CBCL, which consisted of behavioral questions translated into scores for subscales involving being anxious and/or depressed, withdrawn and/or depressed, social problems, thought problems, aggressive behavior, rule-breaking behavior, attention problems, and somatic complaints.

The sample was then divided into four groups; there were 172 children with parents who had a mood disorder but the children did not have CBCL anxiety/depression subsyndromal elevations (high risk group); 22 children without a parental history of mood disorder but had CBCL anxiety/depression subsyndromal elevations (subsyndromal major depressive disorder); 22 children with a parental history of mood disorder and CBCL anxiety/depression subsyndromal elevations (high-risk and subsyndromal major depressive disorder); and 186 children in a control group with no parental history of mood disorder or CBCL anxiety/depression subsyndromal elevations.

Compared with the control group, children with a history of parental mood disorders and children with baseline CBCL anxiety/depression subsyndromal elevations had intermediate risk of developing major depression and anxiety disorders. However, the highest risk was among children with both a parental history of mood disorder and baseline CBCL anxiety/depression subsyndromal elevations.

Using data from two previously collected longitudinal studies was a potential limitation of the study, Dr. Uchida and her associates said, but they noted the CBCL scale has predictive utility for identifying anxiety and depressive disorders in children later in life.

“Considering its simplicity, strong psychometric properties, and limited cost, the CBCL scale lends itself to be used by health professionals and educators in the community,” they wrote.

This study was partly supported by National Institutes of Health and the Massachusetts General Hospital Pediatric Psychopharmacology Council Fund. Joseph Biederman, MD, received research support from Lundbeck AS, Neurocentria, Pfizer, Shire, Sunovion, and others, and has relationships with multiple other associations and pharmaceutical companies. The other authors have no relevant financial disclosures.

SOURCE: Uchida M et al. J Pediatr. 2018 Oct;201:252-8.

Children with elevated scores on the Child Behavior Checklist (CBCL) anxiety/depression scale are at a higher risk of developing major depression and anxiety disorders in later adolescent or adult life, according to research published in the Journal of Pediatrics.

KatarzynaBialasiewicz/Thinkstock

“If confirmed, this observation could have very significant clinical and public health implications in the identification of children at the highest risk for the development of major depressive disorder,” Mai Uchida, MD, of the department of psychiatry at Massachusetts General Hospital in Boston, and colleagues wrote. “Early identification is the first step toward effectively allocating limited societal resources to help prevent illness progression and its associated impairments in children most in need.”

Dr. Uchida and her colleagues analyzed a sample of 537 children aged 6-17 years from two longitudinal studies of children and their parents with and without ADHD, excluding the ADHD probands in their analysis. Parents answered the CBCL, which consisted of behavioral questions translated into scores for subscales involving being anxious and/or depressed, withdrawn and/or depressed, social problems, thought problems, aggressive behavior, rule-breaking behavior, attention problems, and somatic complaints.

The sample was then divided into four groups; there were 172 children with parents who had a mood disorder but the children did not have CBCL anxiety/depression subsyndromal elevations (high risk group); 22 children without a parental history of mood disorder but had CBCL anxiety/depression subsyndromal elevations (subsyndromal major depressive disorder); 22 children with a parental history of mood disorder and CBCL anxiety/depression subsyndromal elevations (high-risk and subsyndromal major depressive disorder); and 186 children in a control group with no parental history of mood disorder or CBCL anxiety/depression subsyndromal elevations.

Compared with the control group, children with a history of parental mood disorders and children with baseline CBCL anxiety/depression subsyndromal elevations had intermediate risk of developing major depression and anxiety disorders. However, the highest risk was among children with both a parental history of mood disorder and baseline CBCL anxiety/depression subsyndromal elevations.

Using data from two previously collected longitudinal studies was a potential limitation of the study, Dr. Uchida and her associates said, but they noted the CBCL scale has predictive utility for identifying anxiety and depressive disorders in children later in life.

“Considering its simplicity, strong psychometric properties, and limited cost, the CBCL scale lends itself to be used by health professionals and educators in the community,” they wrote.

This study was partly supported by National Institutes of Health and the Massachusetts General Hospital Pediatric Psychopharmacology Council Fund. Joseph Biederman, MD, received research support from Lundbeck AS, Neurocentria, Pfizer, Shire, Sunovion, and others, and has relationships with multiple other associations and pharmaceutical companies. The other authors have no relevant financial disclosures.

SOURCE: Uchida M et al. J Pediatr. 2018 Oct;201:252-8.

Children with elevated scores on the Child Behavior Checklist (CBCL) anxiety/depression scale are at a higher risk of developing major depression and anxiety disorders in later adolescent or adult life, according to research published in the Journal of Pediatrics.

KatarzynaBialasiewicz/Thinkstock

“If confirmed, this observation could have very significant clinical and public health implications in the identification of children at the highest risk for the development of major depressive disorder,” Mai Uchida, MD, of the department of psychiatry at Massachusetts General Hospital in Boston, and colleagues wrote. “Early identification is the first step toward effectively allocating limited societal resources to help prevent illness progression and its associated impairments in children most in need.”

Dr. Uchida and her colleagues analyzed a sample of 537 children aged 6-17 years from two longitudinal studies of children and their parents with and without ADHD, excluding the ADHD probands in their analysis. Parents answered the CBCL, which consisted of behavioral questions translated into scores for subscales involving being anxious and/or depressed, withdrawn and/or depressed, social problems, thought problems, aggressive behavior, rule-breaking behavior, attention problems, and somatic complaints.

The sample was then divided into four groups; there were 172 children with parents who had a mood disorder but the children did not have CBCL anxiety/depression subsyndromal elevations (high risk group); 22 children without a parental history of mood disorder but had CBCL anxiety/depression subsyndromal elevations (subsyndromal major depressive disorder); 22 children with a parental history of mood disorder and CBCL anxiety/depression subsyndromal elevations (high-risk and subsyndromal major depressive disorder); and 186 children in a control group with no parental history of mood disorder or CBCL anxiety/depression subsyndromal elevations.

Compared with the control group, children with a history of parental mood disorders and children with baseline CBCL anxiety/depression subsyndromal elevations had intermediate risk of developing major depression and anxiety disorders. However, the highest risk was among children with both a parental history of mood disorder and baseline CBCL anxiety/depression subsyndromal elevations.

Using data from two previously collected longitudinal studies was a potential limitation of the study, Dr. Uchida and her associates said, but they noted the CBCL scale has predictive utility for identifying anxiety and depressive disorders in children later in life.

“Considering its simplicity, strong psychometric properties, and limited cost, the CBCL scale lends itself to be used by health professionals and educators in the community,” they wrote.

This study was partly supported by National Institutes of Health and the Massachusetts General Hospital Pediatric Psychopharmacology Council Fund. Joseph Biederman, MD, received research support from Lundbeck AS, Neurocentria, Pfizer, Shire, Sunovion, and others, and has relationships with multiple other associations and pharmaceutical companies. The other authors have no relevant financial disclosures.

SOURCE: Uchida M et al. J Pediatr. 2018 Oct;201:252-8.

Epidiolex, a cannabis-derived product approved earlier this year by the Food and Drug Administration for the treatment of childhood seizure syndromes, has been reclassified by the Drug Enforcement Administration. This paves the way for the manufacturer to begin marketing Epidiolex, which is expected to be on the market within 6 weeks.

rozmarina/Thinkstock

GW Pharmaceuticals, in a Sept. 27 press release announcing the rescheduling of the company’s oral cannabidiol (CBD) solution, said that the Drug Enforcement Administration had transferred Epidiolex to schedule V, the lowest category of scheduled substances.

The final rescheduling order from the DEA is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinols. In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.

“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS [Lennox-Gastaut syndrome] and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s chief executive officer Justin Gover in a statement from the company announcing the reclassification.

During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndromes, both the FDA and GW Pharmaceuticals assessed the abuse potential for CBD as very low, since it does not contain tetrahydrocannabinol, the primary psychoactive component of cannabis.

All other marijuana products are currently classified as schedule I drugs, along with such illegal substances as heroin and cocaine.

Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary endpoint of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and Dravet syndrome.

Safety evaluations assessed data from 1,756 patients, finding that the 20 deaths seen during the study period were not clearly linked to Epidiolex and not unexpected for children with severe seizure disorders.

In supplementary information accompanying the order, the DEA’s acting administrator, Uttam Dhillon, noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the CSA [Controlled Substances Act]. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.” Schedule I drugs, by definition, do not have a currently accepted medical use.

Schedule V drugs, according to the DEA’s website, are currently defined as “drugs with lower potential for abuse than schedule IV and consist of preparations containing limited quantities of certain narcotics.” Other schedule V drugs include cough medicine with less than 200 mg of codeine/100 mL, antidiarrheal medications, pregabalin (Lyrica), and the antiepileptics brivaracetam (Briviact) and lacosamide (Vimpat). “Schedule V drugs represents the least potential for abuse,” according to the website.

Epidiolex is indicated for adjunctive treatment of seizures in patients with LGS or Dravet syndrome aged 2 years and older. Initial dosing recommendations are to titrate to a dose of 10 mg/kg/day, with dose adjustments permissible up to 20 mg/kg/day depending on clinical response and tolerability. The manufacturer has also submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of another seizure disorder, tuberous sclerosis complex.

koakes@mdedge.com

Epidiolex, a cannabis-derived product approved earlier this year by the Food and Drug Administration for the treatment of childhood seizure syndromes, has been reclassified by the Drug Enforcement Administration. This paves the way for the manufacturer to begin marketing Epidiolex, which is expected to be on the market within 6 weeks.

rozmarina/Thinkstock

GW Pharmaceuticals, in a Sept. 27 press release announcing the rescheduling of the company’s oral cannabidiol (CBD) solution, said that the Drug Enforcement Administration had transferred Epidiolex to schedule V, the lowest category of scheduled substances.

The final rescheduling order from the DEA is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinols. In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.

“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS [Lennox-Gastaut syndrome] and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s chief executive officer Justin Gover in a statement from the company announcing the reclassification.

During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndromes, both the FDA and GW Pharmaceuticals assessed the abuse potential for CBD as very low, since it does not contain tetrahydrocannabinol, the primary psychoactive component of cannabis.

All other marijuana products are currently classified as schedule I drugs, along with such illegal substances as heroin and cocaine.

Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary endpoint of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and Dravet syndrome.

Safety evaluations assessed data from 1,756 patients, finding that the 20 deaths seen during the study period were not clearly linked to Epidiolex and not unexpected for children with severe seizure disorders.

In supplementary information accompanying the order, the DEA’s acting administrator, Uttam Dhillon, noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the CSA [Controlled Substances Act]. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.” Schedule I drugs, by definition, do not have a currently accepted medical use.

Schedule V drugs, according to the DEA’s website, are currently defined as “drugs with lower potential for abuse than schedule IV and consist of preparations containing limited quantities of certain narcotics.” Other schedule V drugs include cough medicine with less than 200 mg of codeine/100 mL, antidiarrheal medications, pregabalin (Lyrica), and the antiepileptics brivaracetam (Briviact) and lacosamide (Vimpat). “Schedule V drugs represents the least potential for abuse,” according to the website.

Epidiolex is indicated for adjunctive treatment of seizures in patients with LGS or Dravet syndrome aged 2 years and older. Initial dosing recommendations are to titrate to a dose of 10 mg/kg/day, with dose adjustments permissible up to 20 mg/kg/day depending on clinical response and tolerability. The manufacturer has also submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of another seizure disorder, tuberous sclerosis complex.

koakes@mdedge.com

Epidiolex, a cannabis-derived product approved earlier this year by the Food and Drug Administration for the treatment of childhood seizure syndromes, has been reclassified by the Drug Enforcement Administration. This paves the way for the manufacturer to begin marketing Epidiolex, which is expected to be on the market within 6 weeks.

rozmarina/Thinkstock

GW Pharmaceuticals, in a Sept. 27 press release announcing the rescheduling of the company’s oral cannabidiol (CBD) solution, said that the Drug Enforcement Administration had transferred Epidiolex to schedule V, the lowest category of scheduled substances.

The final rescheduling order from the DEA is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinols. In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.

“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS [Lennox-Gastaut syndrome] and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s chief executive officer Justin Gover in a statement from the company announcing the reclassification.

During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndromes, both the FDA and GW Pharmaceuticals assessed the abuse potential for CBD as very low, since it does not contain tetrahydrocannabinol, the primary psychoactive component of cannabis.

All other marijuana products are currently classified as schedule I drugs, along with such illegal substances as heroin and cocaine.

Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary endpoint of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and Dravet syndrome.

Safety evaluations assessed data from 1,756 patients, finding that the 20 deaths seen during the study period were not clearly linked to Epidiolex and not unexpected for children with severe seizure disorders.

In supplementary information accompanying the order, the DEA’s acting administrator, Uttam Dhillon, noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the CSA [Controlled Substances Act]. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.” Schedule I drugs, by definition, do not have a currently accepted medical use.

Schedule V drugs, according to the DEA’s website, are currently defined as “drugs with lower potential for abuse than schedule IV and consist of preparations containing limited quantities of certain narcotics.” Other schedule V drugs include cough medicine with less than 200 mg of codeine/100 mL, antidiarrheal medications, pregabalin (Lyrica), and the antiepileptics brivaracetam (Briviact) and lacosamide (Vimpat). “Schedule V drugs represents the least potential for abuse,” according to the website.

Epidiolex is indicated for adjunctive treatment of seizures in patients with LGS or Dravet syndrome aged 2 years and older. Initial dosing recommendations are to titrate to a dose of 10 mg/kg/day, with dose adjustments permissible up to 20 mg/kg/day depending on clinical response and tolerability. The manufacturer has also submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of another seizure disorder, tuberous sclerosis complex.

koakes@mdedge.com

The CDC has developed a guideline for the diagnosis and management of mild traumatic brain injury (mTBI) in children. The guideline was published online ahead of print September 4 in JAMA Pediatrics. To support the “multifaceted approach” that the authors recommend for implementing the guideline, the CDC has created materials such as a screening tool, online training, fact sheets, patient discharge instructions, and symptom-based recovery tips.

The number of emergency department visits for mTBI has increased significantly during the past decade, said the authors, yet no evidence-based clinical guidelines had been drafted in the United States to guide the diagnosis, prognosis, and management of this condition. To fill this gap, the CDC established the Pediatric mTBI Guideline Workgroup, which drafted recommendations based on a systematic review of research published from January 1990 through July 2015.

Diagnosis

The first section of the guideline offers recommendations for diagnosis. Health care professionals should not routinely obtain head CT in children with suspected mTBI, say the authors. They should, however, use validated clinical decision rules to identify children with mTBI at low risk for intracranial injury in whom CT is not indicated, as well as children at higher risk for intracranial injury for whom CT may be warranted. The authors cite the Pediatric Emergency Care Applied Research Network (PECARN) decision rules as an example.

Furthermore, health care professionals should not routinely use brain MRI to evaluate suspected or diagnosed mTBI in children, according to the guideline. No study examining whether this imaging technique is appropriate met the workgroup’s inclusion criteria.

An age-appropriate, validated symptom rating scale should be one component of the diagnostic evaluation, say the authors. The Standardized Assessment of Concussion, however, “should not be exclusively used to diagnose mTBI in children aged 6 to 18,” they add. Finally, the guideline discourages the use of biomarkers (ie, serum markers) for diagnosis outside of a research setting.

Prognosis

The second section of the document provides guidance on developing a prognosis. Clinicians should advise patients and their families that most children with mTBI do not have significant difficulties that last for more than one to three months after injury, say the authors. They also should state that even though certain factors predict a child’s risk for prolonged symptoms, “each child’s recovery from mTBI is unique and will follow its own trajectory.”

Health care professionals should evaluate a child’s premorbid history as soon as possible to help determine the prognosis, say the authors. Children and families should be advised that factors such as history of mTBI, lower cognitive ability, and neurologic disorder can delay recovery from mTBI. Clinicians should screen for known risk factors for persistent symptoms and use a combination of tools (eg, validated symptom scales, cognitive testing, and balance testing) to assess recovery, according to the guideline.

Children with mTBI at high risk for persistent symptoms should be monitored closely. “For children with mTBI whose symptoms do not resolve as expected with standard care (ie, within four to six weeks), health care professionals should provide or refer for appropriate assessments and interventions,” say the authors.

Management and Treatment

The guideline’s section devoted to management and treatment begins with recommendations for returning to normal activities. Clinicians should recommend restricting physical and cognitive activity during the first several days after pediatric mTBI, according to the authors. After that point, doctors should advise patients and families “to resume a gradual schedule of activity that does not exacerbate symptoms, with close monitoring of symptom expression.” If the patient completes this step successfully, the clinician should offer an active rehabilitation program that progressively reintroduces noncontact aerobic activity that does not worsen symptoms. The number and severity of symptoms should be monitored closely throughout the patient’s recovery. A patient should resume full activity when his or her performance returns to its premorbid level, provided that he or she has no symptoms at rest or with increasing levels of exertion, according to the guideline.

“To assist children returning to school after mTBI, medical and school-based teams should counsel the student and family regarding the process of gradually increasing the duration and intensity of academic activities as tolerated, with the goal of increasing participation without significantly exacerbating symptoms,” say the authors. Return-to-school protocols should be adapted to the severity of the child’s postconcussion symptoms. School personnel should assess the need for additional educational support in students with prolonged symptoms that harm their academic performance, according to the guideline.

If a child with mTBI develops severe headache, especially if the headache is associated with other risk factors or has worsened after mTBI, emergency department professionals should observe him or her and consider obtaining a head CT to evaluate for intracranial injury, say the authors. Health care professionals should explain proper sleep hygiene to all patients with mTBI and their families to facilitate recovery.

If a child with mTBI has cognitive dysfunction, clinicians should attempt to determine its etiology within the context of other mTBI symptoms, say the authors. Treatment for cognitive dysfunction should reflect its presumed etiology, they conclude.

—Erik Greb

Suggested Reading

Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

Lumba-Brown A, Yeates KO, Sarmiento K, et al. Diagnosis and management of mild traumatic brain injury in children: a systematic review. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

McCrea M, Manley G. State of the science on pediatric mild traumatic brain injury: progress toward clinical translation. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

The CDC has developed a guideline for the diagnosis and management of mild traumatic brain injury (mTBI) in children. The guideline was published online ahead of print September 4 in JAMA Pediatrics. To support the “multifaceted approach” that the authors recommend for implementing the guideline, the CDC has created materials such as a screening tool, online training, fact sheets, patient discharge instructions, and symptom-based recovery tips.

The number of emergency department visits for mTBI has increased significantly during the past decade, said the authors, yet no evidence-based clinical guidelines had been drafted in the United States to guide the diagnosis, prognosis, and management of this condition. To fill this gap, the CDC established the Pediatric mTBI Guideline Workgroup, which drafted recommendations based on a systematic review of research published from January 1990 through July 2015.

Diagnosis

The first section of the guideline offers recommendations for diagnosis. Health care professionals should not routinely obtain head CT in children with suspected mTBI, say the authors. They should, however, use validated clinical decision rules to identify children with mTBI at low risk for intracranial injury in whom CT is not indicated, as well as children at higher risk for intracranial injury for whom CT may be warranted. The authors cite the Pediatric Emergency Care Applied Research Network (PECARN) decision rules as an example.

Furthermore, health care professionals should not routinely use brain MRI to evaluate suspected or diagnosed mTBI in children, according to the guideline. No study examining whether this imaging technique is appropriate met the workgroup’s inclusion criteria.

An age-appropriate, validated symptom rating scale should be one component of the diagnostic evaluation, say the authors. The Standardized Assessment of Concussion, however, “should not be exclusively used to diagnose mTBI in children aged 6 to 18,” they add. Finally, the guideline discourages the use of biomarkers (ie, serum markers) for diagnosis outside of a research setting.

Prognosis

The second section of the document provides guidance on developing a prognosis. Clinicians should advise patients and their families that most children with mTBI do not have significant difficulties that last for more than one to three months after injury, say the authors. They also should state that even though certain factors predict a child’s risk for prolonged symptoms, “each child’s recovery from mTBI is unique and will follow its own trajectory.”

Health care professionals should evaluate a child’s premorbid history as soon as possible to help determine the prognosis, say the authors. Children and families should be advised that factors such as history of mTBI, lower cognitive ability, and neurologic disorder can delay recovery from mTBI. Clinicians should screen for known risk factors for persistent symptoms and use a combination of tools (eg, validated symptom scales, cognitive testing, and balance testing) to assess recovery, according to the guideline.

Children with mTBI at high risk for persistent symptoms should be monitored closely. “For children with mTBI whose symptoms do not resolve as expected with standard care (ie, within four to six weeks), health care professionals should provide or refer for appropriate assessments and interventions,” say the authors.

Management and Treatment

The guideline’s section devoted to management and treatment begins with recommendations for returning to normal activities. Clinicians should recommend restricting physical and cognitive activity during the first several days after pediatric mTBI, according to the authors. After that point, doctors should advise patients and families “to resume a gradual schedule of activity that does not exacerbate symptoms, with close monitoring of symptom expression.” If the patient completes this step successfully, the clinician should offer an active rehabilitation program that progressively reintroduces noncontact aerobic activity that does not worsen symptoms. The number and severity of symptoms should be monitored closely throughout the patient’s recovery. A patient should resume full activity when his or her performance returns to its premorbid level, provided that he or she has no symptoms at rest or with increasing levels of exertion, according to the guideline.

“To assist children returning to school after mTBI, medical and school-based teams should counsel the student and family regarding the process of gradually increasing the duration and intensity of academic activities as tolerated, with the goal of increasing participation without significantly exacerbating symptoms,” say the authors. Return-to-school protocols should be adapted to the severity of the child’s postconcussion symptoms. School personnel should assess the need for additional educational support in students with prolonged symptoms that harm their academic performance, according to the guideline.

If a child with mTBI develops severe headache, especially if the headache is associated with other risk factors or has worsened after mTBI, emergency department professionals should observe him or her and consider obtaining a head CT to evaluate for intracranial injury, say the authors. Health care professionals should explain proper sleep hygiene to all patients with mTBI and their families to facilitate recovery.

If a child with mTBI has cognitive dysfunction, clinicians should attempt to determine its etiology within the context of other mTBI symptoms, say the authors. Treatment for cognitive dysfunction should reflect its presumed etiology, they conclude.

—Erik Greb

Suggested Reading

Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

Lumba-Brown A, Yeates KO, Sarmiento K, et al. Diagnosis and management of mild traumatic brain injury in children: a systematic review. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

McCrea M, Manley G. State of the science on pediatric mild traumatic brain injury: progress toward clinical translation. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

The CDC has developed a guideline for the diagnosis and management of mild traumatic brain injury (mTBI) in children. The guideline was published online ahead of print September 4 in JAMA Pediatrics. To support the “multifaceted approach” that the authors recommend for implementing the guideline, the CDC has created materials such as a screening tool, online training, fact sheets, patient discharge instructions, and symptom-based recovery tips.

The number of emergency department visits for mTBI has increased significantly during the past decade, said the authors, yet no evidence-based clinical guidelines had been drafted in the United States to guide the diagnosis, prognosis, and management of this condition. To fill this gap, the CDC established the Pediatric mTBI Guideline Workgroup, which drafted recommendations based on a systematic review of research published from January 1990 through July 2015.

Diagnosis

The first section of the guideline offers recommendations for diagnosis. Health care professionals should not routinely obtain head CT in children with suspected mTBI, say the authors. They should, however, use validated clinical decision rules to identify children with mTBI at low risk for intracranial injury in whom CT is not indicated, as well as children at higher risk for intracranial injury for whom CT may be warranted. The authors cite the Pediatric Emergency Care Applied Research Network (PECARN) decision rules as an example.

Furthermore, health care professionals should not routinely use brain MRI to evaluate suspected or diagnosed mTBI in children, according to the guideline. No study examining whether this imaging technique is appropriate met the workgroup’s inclusion criteria.

An age-appropriate, validated symptom rating scale should be one component of the diagnostic evaluation, say the authors. The Standardized Assessment of Concussion, however, “should not be exclusively used to diagnose mTBI in children aged 6 to 18,” they add. Finally, the guideline discourages the use of biomarkers (ie, serum markers) for diagnosis outside of a research setting.

Prognosis

The second section of the document provides guidance on developing a prognosis. Clinicians should advise patients and their families that most children with mTBI do not have significant difficulties that last for more than one to three months after injury, say the authors. They also should state that even though certain factors predict a child’s risk for prolonged symptoms, “each child’s recovery from mTBI is unique and will follow its own trajectory.”

Health care professionals should evaluate a child’s premorbid history as soon as possible to help determine the prognosis, say the authors. Children and families should be advised that factors such as history of mTBI, lower cognitive ability, and neurologic disorder can delay recovery from mTBI. Clinicians should screen for known risk factors for persistent symptoms and use a combination of tools (eg, validated symptom scales, cognitive testing, and balance testing) to assess recovery, according to the guideline.

Children with mTBI at high risk for persistent symptoms should be monitored closely. “For children with mTBI whose symptoms do not resolve as expected with standard care (ie, within four to six weeks), health care professionals should provide or refer for appropriate assessments and interventions,” say the authors.

Management and Treatment

The guideline’s section devoted to management and treatment begins with recommendations for returning to normal activities. Clinicians should recommend restricting physical and cognitive activity during the first several days after pediatric mTBI, according to the authors. After that point, doctors should advise patients and families “to resume a gradual schedule of activity that does not exacerbate symptoms, with close monitoring of symptom expression.” If the patient completes this step successfully, the clinician should offer an active rehabilitation program that progressively reintroduces noncontact aerobic activity that does not worsen symptoms. The number and severity of symptoms should be monitored closely throughout the patient’s recovery. A patient should resume full activity when his or her performance returns to its premorbid level, provided that he or she has no symptoms at rest or with increasing levels of exertion, according to the guideline.

“To assist children returning to school after mTBI, medical and school-based teams should counsel the student and family regarding the process of gradually increasing the duration and intensity of academic activities as tolerated, with the goal of increasing participation without significantly exacerbating symptoms,” say the authors. Return-to-school protocols should be adapted to the severity of the child’s postconcussion symptoms. School personnel should assess the need for additional educational support in students with prolonged symptoms that harm their academic performance, according to the guideline.

If a child with mTBI develops severe headache, especially if the headache is associated with other risk factors or has worsened after mTBI, emergency department professionals should observe him or her and consider obtaining a head CT to evaluate for intracranial injury, say the authors. Health care professionals should explain proper sleep hygiene to all patients with mTBI and their families to facilitate recovery.

If a child with mTBI has cognitive dysfunction, clinicians should attempt to determine its etiology within the context of other mTBI symptoms, say the authors. Treatment for cognitive dysfunction should reflect its presumed etiology, they conclude.

—Erik Greb

Suggested Reading

Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

Lumba-Brown A, Yeates KO, Sarmiento K, et al. Diagnosis and management of mild traumatic brain injury in children: a systematic review. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].

McCrea M, Manley G. State of the science on pediatric mild traumatic brain injury: progress toward clinical translation. JAMA Pediatr. 2018 Sep 4 [Epub ahead of print].