Elizabeth Mechcatie

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.

Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.

Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.

At press time, neither company had posted a news release announcing the approval.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 28 unanimously supported the approval of the oral antiviral drug telaprevir as a treatment for genotype 1 chronic hepatitis C when combined with pegylated interferon and ribavirin, the current standard of care. The combination is to be used in adults with compensated liver disease, including cirrhosis.

At the meeting of the FDA’s Antiviral Drugs Advisory Committee, the panel voted 18-0 that the available data on the risk-benefit profile of the drug supported its approval for treatment of this group of patients, despite the increased risk of rash and anemia associated with the addition of telaprevir. The vote applied to patients who have never received treatment before and those who have been treated previously for genotype 1 hepatitis C virus (HCV), the most common and difficult-to-treat HCV subtype.

In three phase III studies of more than 2,000 treatment-naive and treatment-experienced patients, the addition of telaprevir, an HCV-specific protease inhibitor taken three times a day for up to 12 weeks, to pegylated interferon and ribavirin significantly increased the sustained virologic response (SVR) rate, compared with pegylated interferon and ribavirin therapy. The benefit was seen across a broad range of populations and demographic groups, including in black patients and in those with cirrhosis. (SVR was defined as undetectable HCV RNA levels 24 weeks after the last planned dose of the drug.)

The panel agreed that the risks of rash with treatment, which could be severe and treatment limiting, and the increased risk of anemia with the addition of telaprevir were outweighed by the benefit of the drug, which one panelist described as a "stunning success." Still, they agreed more studies are needed, including in more black patients and in patients over age 65 years.

The manufacturer, Vertex Pharmaceuticals has devised a plan to help clinicians and patients identify and manage rashes and is planning or conducting studies in different populations, including black patients, patients with cirrhosis, patients coinfected with HIV and HCV, post-transplant patients, and children and adolescents aged 3-17 years. The company is also planning to study a twice-daily dosing regimen.

The same advisory panel supported the approval of another oral HCV protease inhibitor, boceprevir, on April 27, for the same indication. Once the two drugs are approved, several panelists noted that it would no longer be considered ethical to conduct treatment studies using pegylated interferon and ribavirin as the control group. And panelists agreed that triple therapy would become the new standard of care, once the protease inhibitors are approved.

The FDA usually follows the recommendations of its advisory panels. A decision on telaprevir is expected by May 23, according to Vertex. Telaprevir is also under review in Canada and the European Union for treating people with genotype 1 chronic hepatitis C.

Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel on April 27 voted 18-0 that the risk-benefit profile of the oral antiviral drug boceprevir supported its approval as a treatment for chronic hepatitis C, in combination with pegylated interferon-alpha and ribavirin, the current standard of care.

At the meeting, members of the FDA’s Antiviral Drugs Advisory Committee agreed that the protease inhibitor was effective when combined with standard therapy for the treatment of patients with chronic hepatitis C genotype-1 infections, the most common and least responsive type of hepatitis C virus (HCV). Despite concerns about some risks associated with treatment, such as an increased rate of anemia, panelists agreed that the risks were manageable and that the benefits of treatment were clear, with some describing it as a "marvelous" or "tremendous" advance in the treatment of chronic HCV.

But the panel emphasized the importance of appropriate patient selection and physician education about how to use the drug-as well as the need for postmarketing studies on drug-drug interactions and in different patient populations, such as in people over age 65 years and liver transplant recipients.

The recommended dosage of boceprevir, a potent inhibitor of HCV replication, is 800 mg three times a day, every 7-9 hours with food. The proposed indication is for the treatment of adults with compensated liver disease, who either have not been treated previously or who have failed previous therapy.

The addition of boceprevir to peginterferon-alpha and ribavirin for up to 44 weeks of therapy resulted in significant increase in efficacy of the standard of care regimen, based on sustained virologic responses, in two phase III studies: one study of 403 patients who had previously failed treatment (N. Engl. J. Med. 2011 March 31;364:1207-17) and another study of more than 1,097 treatment-naive patients (N. Engl. J. Med. 2011 March 31;364:1195-206). The safety of boceprevir was based on data from the two phase III studies and a phase II study of 595 treatment-naive patients: In the three trials, the two adverse events that occurred more than 20% more frequently among those treated with all three drugs, compared with those treated with the interferon-ribavirin combination, were anemia (49% vs. 29%) and dysgeusia (37% vs. 15%.).

The FDA usually follows the recommendations of its advisory panels, Panel members have been cleared of potential conflicts of interest related to the topic of the meeting, although occasionally, may be given a waiver, but not at this meeting.

Boceprevir is manufactured by Merck Research Laboratories If approved, Merck plans to market boceprevir as Victrelis. A decision on approval is expected by mid-May, according to the company. It is also under review as a treatment for chronic hepatitis C in the European Union.

On April 28, the same panel will review telaprevir, another HCV protease inhibitor as a treatment for chronic hepatitis C.

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia "or neurological compromise," according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as "a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason." That does not include a symptom such as visual loss that is related to the lesion, "but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma."

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

"Fortunately, incidentalomas are almost always benign and usually do not need surgery," Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, "indicating when surgical therapy may be necessary," she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an "unremitting headache," or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination "that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome," as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a "significant financial interest" or a "leadership position" within the pharmaceutical industry. Dr. Freda’s disclosure states that she has "financial, business or organization interests" in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia "or neurological compromise," according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as "a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason." That does not include a symptom such as visual loss that is related to the lesion, "but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma."

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

"Fortunately, incidentalomas are almost always benign and usually do not need surgery," Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, "indicating when surgical therapy may be necessary," she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an "unremitting headache," or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination "that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome," as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a "significant financial interest" or a "leadership position" within the pharmaceutical industry. Dr. Freda’s disclosure states that she has "financial, business or organization interests" in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia "or neurological compromise," according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as "a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason." That does not include a symptom such as visual loss that is related to the lesion, "but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma."

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

"Fortunately, incidentalomas are almost always benign and usually do not need surgery," Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, "indicating when surgical therapy may be necessary," she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an "unremitting headache," or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination "that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome," as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a "significant financial interest" or a "leadership position" within the pharmaceutical industry. Dr. Freda’s disclosure states that she has "financial, business or organization interests" in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia "or neurological compromise," according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as "a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason." That does not include a symptom such as visual loss that is related to the lesion, "but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma."

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

"Fortunately, incidentalomas are almost always benign and usually do not need surgery," Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, "indicating when surgical therapy may be necessary," she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an "unremitting headache," or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination "that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome," as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a "significant financial interest" or a "leadership position" within the pharmaceutical industry. Dr. Freda’s disclosure states that she has "financial, business or organization interests" in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia "or neurological compromise," according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as "a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason." That does not include a symptom such as visual loss that is related to the lesion, "but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma."

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

"Fortunately, incidentalomas are almost always benign and usually do not need surgery," Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, "indicating when surgical therapy may be necessary," she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an "unremitting headache," or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination "that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome," as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a "significant financial interest" or a "leadership position" within the pharmaceutical industry. Dr. Freda’s disclosure states that she has "financial, business or organization interests" in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia "or neurological compromise," according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as "a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason." That does not include a symptom such as visual loss that is related to the lesion, "but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma."

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

"Fortunately, incidentalomas are almost always benign and usually do not need surgery," Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, "indicating when surgical therapy may be necessary," she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an "unremitting headache," or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination "that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome," as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a "significant financial interest" or a "leadership position" within the pharmaceutical industry. Dr. Freda’s disclosure states that she has "financial, business or organization interests" in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.