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FDA Eyes Possible Precancerous Changes With Diabetes Drugs
The FDA is evaluating unpublished findings by a group of academic researchers that suggest an increased risk of pancreatitis and precancerous cellular changes (pancreatic duct metaplasia) in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. The findings were based on the examination of a small number of pancreatic tissue specimens obtained from patients after they died from unspecified causes.
The FDA has asked the researchers to provide the methods used to collect and study these specimens and to provide the tissue samples so that the agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.
Drugs in the incretin mimetic class include exenatide (Byetta, Amyn Pharmaceuticals); liraglutide (Victoza, Novo Nordisk); sitagliptin (Januvia, Merck); saxagliptin (Onglyza, Bristol Myers-Squibb/AstraZeneca); alogliptin (Nesina, Furiex Pharmaceuticals); and linagliptin (Tradjenta, Boehringer Ingelheim/Eli Lilly). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
The FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. The agency previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of the incretin mimetics exanitide and sitagliptin. A recently published study that examined insurance records also found that the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis. The “Warnings and Precautions” section of the drug labels and the patient medication guides for incretin mimetic drugs contain warnings about the risk of acute pancreatitis.
The FDA has not previously communicated about the potential risk of precancerous findings of the pancreas with incretin mimetics. Further, the agency has not concluded that these drugs may cause or contribute to the development of pancreatic cancer.
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, the agency says.
Source: FDA; March 14, 2013.