FDA Not Concerned About Januvia Side Effects, but Consumers Might Be

Washington, DCThe US Food and Drug Administration (FDA) has said it will not update the warning label regarding Januvia side effects because there is no evidence to confirm a link between the drugs and an increased risk of pancreatic cancer. Even though the FDA has taken such a stance, patients have filed Januvia lawsuits, alleging a link between Januvia and cancer. Meanwhile, other health agencies have said they believe there is a link between the drug and pancreatic cancer.

One of the issues for critics of Januvia is that Januvia has been linked in studies to an increased risk pancreatitis. One study, published online in JAMA (2/25/13), found that diabetes patients with pancreatitis were more likely to be on Byetta or Januvia than patients with diabetes who did not have pancreatitis.

Pancreatitis is not the same as having cancer, but pancreatitis is widely seen as a risk factor of pancreatic cancer. In other words, patients who develop pancreatitis are at an increased risk of developing pancreatic cancer.

The American Diabetes Association released a statement on June 28, 2013, noting that there currently is “insufficient information to modify current treatment recommendations.” That said, the organization also wrote that people taking Januvia and other drugs in its class should be informed of all that is known about the potential for risks and advantages, so they can make an informed decision.

“Recent epidemiologic studies, rodent studies, and a recent human autopsy study raised concerns that these agents (predominantly sitagliptin and exenatide, by virtue of their time on the market and thus longer patient exposure), may be associated with pancreatic changes ranging from pancreatitis to premalignant lesions,” the ADA wrote. It also noted, however, that there was a link between the diabetes and an increased risk of pancreatic cancer, and the FDA found no risk of pancreatic disease associated with the use of incretin mimetics (the class of drug Januvia belongs to).

Patients who have developed pancreatic cancer after using Januvia have filed lawsuits against the maker of the diabetes medication, alleging they were not properly warned about the risks associated with the drug. There are reportedly more than 100 lawsuits filed across the US alleging patients were harmed by the use of incretin drugs such as Januvia. The multidistrict litigation number is MDL 2452.