Doctor Knew of Problems with Januvia in 2008

Washington, DCMerck, the maker of sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), is, according to The New York Times, facing 43 personal injury lawsuits alleging Januvia caused pancreatic cancer. But Merck is not the only pharmaceutical company facing legal action over adverse event profiles associated with this class of drugs: over 100 lawsuits claiming injury from Byetta, mostly pancreatitis, according to the latest quarterly regulatory filing from Bristol-Myers.

In April, the US Food and Drug Administration (FDA) issued statement notifying the public that it is “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular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.”

However, these findings may not be new. In an interview with The New York Times, Dr. Peter C. Butler, chief of the division of endocrinology at the University of California, Los Angeles, and lead investigator in the study that has prompted the FDA review, said he knew something was wrong back in 2008, when he concluded initial studies on Januvia for Merck.

He found evidence of changes in the pancreases of the rats that could lead to pancreatic cancer. The findings have turned Dr. Butler into a crusader, who some liken to the well-known Cleveland Clinic cardiologist, Dr. Steven Nissen, whose warnings about another type of diabetes drug, Avandia, resulted in its being banned in Europe and highly restricted in the US.

Dr. Butler has done follow-up studies, the results of which now threaten the future of not only Januvia but all the drugs in its class, which include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). “I knew some stuff that I thought was a worry and I was obliged to pursue it,” Dr. Butler told The New York Times.

At the moment, the argument is that the data are inconclusive, for a variety of reasons. However, this June a meeting is planned by the National Institutes of Health to review the possible links between diabetes, diabetes drugs and pancreatic cancer. More information should be available then, and Dr. Butler will be one of the speakers.