FDA to probe new diabetes drugs, precancerous changes in pancreas

The Food and Drug Administration has announced that it will investigate whether a new class of Type 2 diabetes drugs sometimes called the “gliptins” may increase patients’ risk of developing precancerous changes in the pancreas, as well as of developing acute pancreatitis.

The drugs now under closer FDA scrutiny are called incretin mimetics and include such widely prescribed medications as the drug exenitide (marketed as Byetta and Bydureon), liraglutide (Victoza), sitagliptin (Januvia and Janumet or Juvisync), saxagliptin (Onglyza), alogliptin (Nesina, Kazano and Oseni) and linogliptin (Tradjenta and Jentadueto). All of the drugs in this class help Type 2 diabetes patients control their blood sugar by mimicking the hormones that promote the release of insulin after a meal.

The FDA already has issued consumer warnings that patients taking these diabetes drugs may be at higher risk of developing acute pancreatitis, an inflammation of the gland that secretes insulin and the enzymes needed to digest food and extract their nutrients. But the agency said an as-yet unpublished study found that pancreatic cells taken from patients who had died of unspecified causes had developed precancerous cellular changes called pancreatic duct metaplasia.

FDA investigators have asked those researchers to share their methods and findings with the agency so that they can “investigate potential pancreatic toxicity associated with the incretin mimetics.”

The FDA announcement emphasized that the agency “has not reached any new conclusions about safety risks” that may comes with these medications’ use. Until their investigation is complete, they urged consumers to continue to take the medications as prescribed and urged physicians to continue to follow prescribing guidelines on the medications’ labels. As is typical, the agency is calling on patients and physicians to report any “adverse events” they may experience while on these medications.

Drugs to treat diabetes are the fourth-most commonly dispensed class of prescription medications in the United States, and their market is growing, as sedentary behavior and obesity have made diabetes rates surge. IMS Health, which tracks prescribing trends, found that 173 million prescriptions for diabetes medications were dispensed in 2011. The incretin mimetics are among the newest of these.