FDA Opens Investigation into Januvia and Pancreatitis

Washington, DCReports of pancreatitis associated with type 2 diabetes medications, including Merck’s Januvia and Bristol-Myers Squibb’s Byetta and Bydureon, have prompted the Food and Drug Administration (FDA) to begin a safety review.

In a recent statement, the FDA said they are “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics."

The FDA review is prompted by both new evidence and older reports of adverse events linked with the drugs. In February 2013, researchers at Johns Hopkins published a study in JAMA Internal Medicine, (2/25/13), that showed people taking Byetta, Bydureon or Januvia had double the rate of acute pancreatitis.

Doctor Edwin A. M. Gale, professor of diabetes medicine at Southmead Hospital in England commented on those data in the British Medical Journal, saying, “Should we be worried about this? Very much so. All forms of pancreatitis, clinical or subclinical, predispose to carcinoma of the pancreas.” He added that the number of reports of pancreatitis associated with the new generation type 2 diabetes medications that have been received by the FDA have reached “astronomical proportions.”

The JAMA study found that patients hospitalized with pancreatitis were two times more likely to be taking either Januvia or Byetta than diabetic patients who did not have pancreatitis. The study concerned Consumer Reports (3/5/13) enough that it issued an article warning patients to talk to their doctor about switching to another medication.