Januvia Safety Risks: Mixed Messages from FDA and Researchers

Washington, DCAlthough a new study has linked Merck’s Januvia with pancreatitis, the FDA is not changing Januvia’s labeling about potential safety risks - for now. Meanwhile, the agency says a review is “ongoing” as Januvia pancreatitis and data are being collected.

Despite a 2011 study from UCLA that showed increased rates of Januvia pancreatic cancer and thyroid cancer, and The American Medical Association report that diabetes drugs like Januvia can double the risk of pancreatitis, the FDA advised that, “for now,” there is no evidence to show that Januvia is associated with higher cancer rates.

One study, which was published in the journal JAMA Internal Medicine (published
online Feb. 25, 2013), analyzed insurance records to find that patients hospitalized with pancreatitis were twice as likely to be using Januvia or Byetta, compared with diabetes patients who didn’t have pancreatitis. In the wake of that study, the FDA announced in March 2013 it was investigating a potential connection between Januvia and Byetta and acute pancreatitis and pre-cancerous changes to the pancreas.

BMJ (the British Medical Journal) published a report that included a former FDA reviewer alluding that the agency defended the drug company Merck by not giving any warning at all about sitagliptin (Januvia) and pancreatic disease. According to NewsInferno, the former reviewer contacted the FDA and asked why it hadn’t issued warnings about the associated effects of the drug. The agency was also asked about the JAMA study and its database showing a signal for pancreatic cancer. Shortly afterward, the FDA released a safety alert for Januvia and pancreatitis.

Januvia Litigation Update

Also in March 2013, a wrongful death claim was brought against Merck, alleging Januvia is defective, that Merck failed to warn of Januvia risks and Januvia caused fatal pancreatic cancer in three patients.

By July 2013, fifty-three Januvia lawsuits had been filed in federal court. On July 25, The United States Judicial Panel on Multidistrict Litigation discussed whether or not to transfer the Januvia cases to a multidistrict litigation (MDL) in one federal court for pre-trial proceedings (In Re: Incretins Products Liability, Sales and Marketing Litigation, MDL 2452, United States Judicial Panel on Multidistrict Litigation).

Januvia is one of the biggest-selling diabetes drugs, bringing Merck revenues exceeding $2.6 billion last year. Januvia was approved by the FDA in 2006, with sales of $9.808 billion from 2006 to 2011.