Pharmaceutical

FDA investigates cases of pancreatitis, precancerous pancreatic cancer with type 2 diabetes treatments

diabetes illus250x03 FDA investigates cases of pancreatitis, precancerous pancreatic cancer with type 2 diabetes treatmentsAn increased risk of pancreatitis, or inflammation of the pancreas, and other precancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics is being evaluated by the Food and Drug Administration (FDA). The investigation is based on unpublished findings by a group of academic researchers who examined a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.

Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). 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 previously warned the public that cases of acute pancreatitis, including fatal and serious nonfatal cases, have been associated with the use of incretin mimetic drugs exenatide and sitagliptin, including a recently published study that found the use of exenatide and sitagliptin could double the risk of developing acute pancreatitis. As a result, the Warnings and Precautions sections on the safety labels of these drugs were updated to include this warning. The agency has not previously communicated about the potential risk of precancerous findings of the pancreas with incretin mimetics, nor has the agency concluded these drugs may cause or contribute to the development of pancreatic cancer.

At this time the FDA is recommending patients continue to take their medication as directed by their physicians, and to talk with their doctors if they have questions. The agency will issue a recommendation after it completes its investigation of this class of drugs.

Drugs to treat type 2 diabetes have come under closer scrutiny of the FDA in recent years. In 2010 the agency severely restricted the use of Avandia after the drug had been linked to fatal heart attacks. A year later, the agency issued a warning that Actos had been tied to bladder cancer.

Source: FDA