Elizabeth Mechcatie

ADELPHI, MD. – A Food and Drug Administration advisory panel on June 21 voted 11-1 that the data on canakinumab did not support its approval as a treatment for gouty arthritis attacks, in patients who have not responded adequately to nonsteroidal anti-inflammatory drugs or colchicine.

Members of the FDA’s Arthritis Advisory Committee considered canakinumab a promising treatment, and all but one panelist agreed that the 150-mg subcutaneous dose that was studied in two phase III trials was shown to be effective in treating an attack of gouty arthritis in this population.

But, in another vote, the panel unanimously agreed that the safety profile of canakinumab did not support approval for this indication, because of concerns that included the lack of long-term safety data including the potential long-term risk of infections and the lack of data on the effects of recurrent treatment. (Only 43 patients in the studies had received three or more injections and most had been treated only once.)

The need for more data in likely patient candidates who are less healthy than those in the trials, such as those with advanced renal disease, was another concern cited by the panel. Several panelists also expressed concern that unless use was restricted in some way, canakinumab might be used to treat a broader population than described in the proposed indication.

Canakinumab (Ilaris), a monoclonal antibody that neutralizes interleukin-1beta, was approved in June 2009 for the treatment of a rare disorder, cryopyrin-associated periodic syndromes (CAPS). The new indication proposed by the manufacturer, Novartis Pharmaceuticals, is for the treatment of gouty arthritis attacks in patients who cannot obtain an adequate response with NSAIDs or colchicine.

The company described canakinumab as the first targeted anti-inflammatory treatment for gout, which could be used to treat about 6% of the patients with gouty arthritis, an estimated 300,000 patients in the United States.

In the two phase III trials of approximately 450 patients, most of whom were male and white, (mean age was early 50s) with at least three gouty arthritis attacks a year, a single 150-mg injection of canakinumab, was compared with an intramuscular injection of triamcinolone (40 mg) in treating an acute attack.

Those treated with canakinumab had significantly greater reductions in pain intensity of the affected joint, as measured by changes in a visual pain scale (a primary end point) 72 hours after the injection, compared with those treated with triamcinolone. The risk of having another gouty arthritis flare over the 12 weeks after treatment – the other primary end point – was also significantly reduced among those treated with canakinumab, compared with those on triamcinolone.

The rates of adverse events, including serious adverse events, were higher among those treated with canakinumab, compared with those on triamcinolone and included infections (19% vs. 13%, respectively) and serious infections (2% vs. 0%, respectively). Treatment with canakinumab also was associated with an increase in serum triglycerides levels, declines in renal function, and elevations in serum uric acid, and hypertension. There were three cases of renal failure among gout patients treated with canakinumab, who had predisposing factors, according to the company.

Canakinumab is under review in the European Union for the same indication.

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

ADELPHI, MD. – A Food and Drug Administration advisory panel on June 21 voted 11-1 that the data on canakinumab did not support its approval as a treatment for gouty arthritis attacks, in patients who have not responded adequately to nonsteroidal anti-inflammatory drugs or colchicine.

Members of the FDA’s Arthritis Advisory Committee considered canakinumab a promising treatment, and all but one panelist agreed that the 150-mg subcutaneous dose that was studied in two phase III trials was shown to be effective in treating an attack of gouty arthritis in this population.

But, in another vote, the panel unanimously agreed that the safety profile of canakinumab did not support approval for this indication, because of concerns that included the lack of long-term safety data including the potential long-term risk of infections and the lack of data on the effects of recurrent treatment. (Only 43 patients in the studies had received three or more injections and most had been treated only once.)

The need for more data in likely patient candidates who are less healthy than those in the trials, such as those with advanced renal disease, was another concern cited by the panel. Several panelists also expressed concern that unless use was restricted in some way, canakinumab might be used to treat a broader population than described in the proposed indication.

Canakinumab (Ilaris), a monoclonal antibody that neutralizes interleukin-1beta, was approved in June 2009 for the treatment of a rare disorder, cryopyrin-associated periodic syndromes (CAPS). The new indication proposed by the manufacturer, Novartis Pharmaceuticals, is for the treatment of gouty arthritis attacks in patients who cannot obtain an adequate response with NSAIDs or colchicine.

The company described canakinumab as the first targeted anti-inflammatory treatment for gout, which could be used to treat about 6% of the patients with gouty arthritis, an estimated 300,000 patients in the United States.

In the two phase III trials of approximately 450 patients, most of whom were male and white, (mean age was early 50s) with at least three gouty arthritis attacks a year, a single 150-mg injection of canakinumab, was compared with an intramuscular injection of triamcinolone (40 mg) in treating an acute attack.

Those treated with canakinumab had significantly greater reductions in pain intensity of the affected joint, as measured by changes in a visual pain scale (a primary end point) 72 hours after the injection, compared with those treated with triamcinolone. The risk of having another gouty arthritis flare over the 12 weeks after treatment – the other primary end point – was also significantly reduced among those treated with canakinumab, compared with those on triamcinolone.

The rates of adverse events, including serious adverse events, were higher among those treated with canakinumab, compared with those on triamcinolone and included infections (19% vs. 13%, respectively) and serious infections (2% vs. 0%, respectively). Treatment with canakinumab also was associated with an increase in serum triglycerides levels, declines in renal function, and elevations in serum uric acid, and hypertension. There were three cases of renal failure among gout patients treated with canakinumab, who had predisposing factors, according to the company.

Canakinumab is under review in the European Union for the same indication.

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

ADELPHI, MD. – A Food and Drug Administration advisory panel on June 21 voted 11-1 that the data on canakinumab did not support its approval as a treatment for gouty arthritis attacks, in patients who have not responded adequately to nonsteroidal anti-inflammatory drugs or colchicine.

Members of the FDA’s Arthritis Advisory Committee considered canakinumab a promising treatment, and all but one panelist agreed that the 150-mg subcutaneous dose that was studied in two phase III trials was shown to be effective in treating an attack of gouty arthritis in this population.

But, in another vote, the panel unanimously agreed that the safety profile of canakinumab did not support approval for this indication, because of concerns that included the lack of long-term safety data including the potential long-term risk of infections and the lack of data on the effects of recurrent treatment. (Only 43 patients in the studies had received three or more injections and most had been treated only once.)

The need for more data in likely patient candidates who are less healthy than those in the trials, such as those with advanced renal disease, was another concern cited by the panel. Several panelists also expressed concern that unless use was restricted in some way, canakinumab might be used to treat a broader population than described in the proposed indication.

Canakinumab (Ilaris), a monoclonal antibody that neutralizes interleukin-1beta, was approved in June 2009 for the treatment of a rare disorder, cryopyrin-associated periodic syndromes (CAPS). The new indication proposed by the manufacturer, Novartis Pharmaceuticals, is for the treatment of gouty arthritis attacks in patients who cannot obtain an adequate response with NSAIDs or colchicine.

The company described canakinumab as the first targeted anti-inflammatory treatment for gout, which could be used to treat about 6% of the patients with gouty arthritis, an estimated 300,000 patients in the United States.

In the two phase III trials of approximately 450 patients, most of whom were male and white, (mean age was early 50s) with at least three gouty arthritis attacks a year, a single 150-mg injection of canakinumab, was compared with an intramuscular injection of triamcinolone (40 mg) in treating an acute attack.

Those treated with canakinumab had significantly greater reductions in pain intensity of the affected joint, as measured by changes in a visual pain scale (a primary end point) 72 hours after the injection, compared with those treated with triamcinolone. The risk of having another gouty arthritis flare over the 12 weeks after treatment – the other primary end point – was also significantly reduced among those treated with canakinumab, compared with those on triamcinolone.

The rates of adverse events, including serious adverse events, were higher among those treated with canakinumab, compared with those on triamcinolone and included infections (19% vs. 13%, respectively) and serious infections (2% vs. 0%, respectively). Treatment with canakinumab also was associated with an increase in serum triglycerides levels, declines in renal function, and elevations in serum uric acid, and hypertension. There were three cases of renal failure among gout patients treated with canakinumab, who had predisposing factors, according to the company.

Canakinumab is under review in the European Union for the same indication.

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

An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.

Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.

TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.

In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.

The recalled risperidone products are:

• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.

• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.

The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.

An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.

Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.

TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.

In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.

The recalled risperidone products are:

• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.

• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.

The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.

An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.

Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.

TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.

In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.

The recalled risperidone products are:

• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.

• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.

The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.

An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.

Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.

TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.

In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.

The recalled risperidone products are:

• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.

• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.

The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.

An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.

Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.

TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.

In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.

The recalled risperidone products are:

• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.

• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.

The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.

An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.

Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.

TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.

In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.

The recalled risperidone products are:

• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.

• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.

The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

Treatment with the diabetes drug pioglitazone for more than 1 year may increase the risk of bladder cancer, the Food and Drug Administration announced in a safety communication issued on June 15.

A review of the 5-year data from an ongoing 10-year epidemiologic study of almost 200,000 patients with type 2 diabetes in the Kaiser Permanente Northern California health plan found that overall, there was no increased risk of bladder cancer among the patients who were treated with pioglitazone, compared with those who had never been treated with the drug, after adjusting for age, sex, use of tobacco products, use of other types of diabetes medications, and other risk factors. However, the risk did increase with higher doses and increasing duration of treatment: Treatment with pioglitazone for more than 12 months was associated with a 40% increase in the risk of bladder cancer, according to the FDA.

Pioglitazone, marketed as Actos, is approved for treating type 2 diabetes, and is also available in combination with metformin (Actoplus Met, Actoplus Met XR) and with glimepiride (Duetact).

The FDA is recommending that pioglitazone not be used in patients with active bladder cancer, and that it be used cautiously in patients with a history of bladder cancer.

The FDA is continuing to review the data from the 10-year study being conducted by the manufacturer, Takeda Pharmaceuticals North America, specifically to examine this association, and also plans to review the results of a French study that also found a significantly increased risk of bladder cancer associated with pioglitazone treatment, seen in men only. That study prompted French authorities to suspend the use of the drug in France and German authorities to recommend against starting pioglitazone treatment in new patients, earlier this month.

The statement is available at http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or http://www.fda.gov/medwatch/.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

A test that measures the number of copies of the HER2 gene in breast tumor tissue has been approved by the Food and Drug Administration, the agency announced on June 14.

If the Inform Dual ISH test is positive, then the patient is a candidate for treatment with trastuzumab, the recombinant monoclonal antibody directed against HER2 that is marketed as Herceptin by Genentech for the treatment of HER-2 overexpressing breast cancer.

The test is manufactured by Tucson, Ariz.–based Ventana Medical Systems, a member of the Roche group, as is Genentech.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

The test makes it possible "to see and count copies of chromosome 17 and HER2 genes on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes," the statement said. But the new test, "allows lab staff to see the HER2 and chromosome 17 signals directly under a microscope, for longer periods of time."

Approval is based on a study conducted in the United States that evaluated the test in 510 women with breast cancer. The test confirmed that the tumor sample contained more than the normal number of copies of the HER-2 gene, located on chromosome 17, in 96% of the HER-2 positive samples, according to the statement.

The test also excluded the possibility that an excessive number of HER2 genes was present in 92.3% of the HER2-negative samples.

About 20% of women diagnosed with breast cancer are HER2-positive, according to the FDA.

The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.

The information is not new, but the letter is being sent to clinicians because "a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.

Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.

More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.

The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.

The information is not new, but the letter is being sent to clinicians because "a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.

Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.

More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.

The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.

The information is not new, but the letter is being sent to clinicians because "a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.

Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.

More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.