Many a Wary Eye Watching the Potential for Januvia Pancreatic Cancer

Washington, DCWhen the medical and regulatory communities start to gang up on you with post-market studies and independent reviews, the only thing a manufacturer can do is to put as positive a spin as possible on the issue. Such is the case with Merck & Co., the manufacturer and distributor of type 2 diabetes drug Januvia, in the wake of renewed concern over Januvia side effects.

In a release, Michael Rosenblatt, MD, who serves as chief medical officer for Merck, defended the drug and welcomed the renewed scrutiny. “Nothing is more important to Merck than the safety of our medicines and the people who take them. We welcome opportunities to discuss the data that support the safety profile of sitagliptin in the treatment of adults with type 2 diabetes. Type 2 diabetes is a disease with serious consequences if left untreated,” said Dr. Rosenblatt, in the statement. “We are committed to participating in an independent review of our data, and will join the [American Diabetes Association, ADA] in planning for such an initiative.”

The independent review about which Rosenblatt refers has been requested by the ADA. And it’s not just Januvia, either. All incretin-based drugs, the class that includes sitagliptin (Januvia), will be put under the microscope.

The US Food and Drug Administration (FDA) is also keeping a wary post-market eye on Januvia, especially given more recent reports that concern over the potential for Januvia pancreatic cancer has increased. One such report recently appeared in the British Medical Journal.

The concern over Januvia cancer is not new. According to a Bloomberg (3/14/13) report earlier this spring, the FDA has had the issue on its radar since 2007, when it sounded the alarm over a high number of reports involving Byetta patients and pancreatic cancer. Byetta, also a Merck drug, is in the same class as Januvia. Sure enough, two years later in 2009, the FDA issued a similar warning for Januvia.

More recently, concern over Januvia and cancer was raised yet again when researcher Dr. Peter Butler released a preliminary study that suggested the need for continued caution. “When new drugs come out, the long-term side effects of these drugs are not well understood,” Butler said, in comments published in USA Today (9/23/11). Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles, noted at the time that the results, while fairly exhaustive, were preliminary and that it was important not to be alarmist. “We have raised concern that there may be a link, but we haven’t confirmed it. We need to do more work to figure out whether this is real or not.”

It’s looking more and more like it might be real. A spokesperson for the British Medical Journal noted that when one looks at various sources of emerging data viewed collectively a worrisome picture emerges, raising serious doubts (if not definitive conclusions) about the safety of the class of drugs to which Januvia belongs.

Dr. Butler pointed out in comments to Bloomberg that patients should never simply dump a medication that appears to be working for them - especially in keeping their type 2 diabetes in check. However, if any patient has concerns over Januvia and pancreatitis, a chat with their doctor would certainly be in order.

In the meantime, Merck continues to stand behind Januvia and maintains confidence in the safety and efficacy of sitagliptin. The FDA continues to watch and wait. And some 43 Januvia pancreatic cancer lawsuits waiting potential MDL consolidation suggest that for some users of Januvia, the risk for Januvia pancreatitis escalated from a risk to a real and grievous threat to their health.