Diabetes Meds Face FDA Scrutiny for Pancreas Risks
Diabetes Meds Face FDA Scrutiny for Pancreas Risks
March 14, 2013 -- The FDA is looking into an increased risk of pancreatitis and precancerous changes to the pancreas from widely used drugs to treat type 2 diabetes.
The medications are called incretin mimetics, which mimic a natural hormone in the body that tells the pancreas to release more insulin after eating. Insulin, in turn, lowers the person's blood sugar. Included in this class are the drugs Bydureon, Byetta, Janumet, Janumet XR, Januvia, Juvisync, Kazano, Kombiglyze XR, Nesina, Onglyza, Oseni, Tradjenta, and Victoza.
Some are a pill and others are an injection.
This is the first time the FDA has issued a communication with regard to the potential risk of precancerous findings of the pancreas with these types of drugs. It emphasizes, however, that it "has not concluded these drugs may cause or contribute to the development of pancreatic cancer."
The FDA wants to further investigate this potential risk, but says it "has not reached any new conclusions about safety risks with incretin mimetic drugs."
And it stresses: "At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels."
12 Tips to Avoid Diabetes Complications
The FDA has previously alerted the public to reports of acute pancreatitis, including fatal and serious nonfatal cases, linked to Byetta and Januvia. The drug labels and medication guides for incretin mimetics contain warnings about the risk of acute pancreatitis, it notes.
Most recently, a study published last month that examined insurance records found the use of Byetta or Januvia could double the risk of developing acute pancreatitis. But the researchers of that study also urged patients not to stop taking their medication.
A joint statement from the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association called into question the strength of the study's findings, noting that the analysis linked the drug class with a relatively small excess risk of hospitalization for acute pancreatitis (only 2 additional cases per 100 patients over a 3-year period). Both AACE and ADA reiterated that patients should not change their treatment on the basis of this research.
The FDA says it is continuing to evaluate all available data to further understand this potential safety issue.
The FDA will communicate its final conclusions and recommendations when its review is complete, or when the agency has additional information to report.
In the meantime, it urges both patients and health care professionals to report adverse events involving incretin mimetics to the FDA MedWatch program.
To see a version of this story for physicians, visit Medscape, the leading site for physicians and health care professionals.
Diabetes Meds Face FDA Scrutiny for Pancreas Risks
March 14, 2013 -- The FDA is looking into an increased risk of pancreatitis and precancerous changes to the pancreas from widely used drugs to treat type 2 diabetes.
The medications are called incretin mimetics, which mimic a natural hormone in the body that tells the pancreas to release more insulin after eating. Insulin, in turn, lowers the person's blood sugar. Included in this class are the drugs Bydureon, Byetta, Janumet, Janumet XR, Januvia, Juvisync, Kazano, Kombiglyze XR, Nesina, Onglyza, Oseni, Tradjenta, and Victoza.
Some are a pill and others are an injection.
This is the first time the FDA has issued a communication with regard to the potential risk of precancerous findings of the pancreas with these types of drugs. It emphasizes, however, that it "has not concluded these drugs may cause or contribute to the development of pancreatic cancer."
The FDA wants to further investigate this potential risk, but says it "has not reached any new conclusions about safety risks with incretin mimetic drugs."
And it stresses: "At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels."
12 Tips to Avoid Diabetes Complications
Not the First Warning
The FDA has previously alerted the public to reports of acute pancreatitis, including fatal and serious nonfatal cases, linked to Byetta and Januvia. The drug labels and medication guides for incretin mimetics contain warnings about the risk of acute pancreatitis, it notes.
Most recently, a study published last month that examined insurance records found the use of Byetta or Januvia could double the risk of developing acute pancreatitis. But the researchers of that study also urged patients not to stop taking their medication.
A joint statement from the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association called into question the strength of the study's findings, noting that the analysis linked the drug class with a relatively small excess risk of hospitalization for acute pancreatitis (only 2 additional cases per 100 patients over a 3-year period). Both AACE and ADA reiterated that patients should not change their treatment on the basis of this research.
The FDA says it is continuing to evaluate all available data to further understand this potential safety issue.
The FDA will communicate its final conclusions and recommendations when its review is complete, or when the agency has additional information to report.
In the meantime, it urges both patients and health care professionals to report adverse events involving incretin mimetics to the FDA MedWatch program.
To see a version of this story for physicians, visit Medscape, the leading site for physicians and health care professionals.
