Thursday, June 27, 2013

Latest FDA Warnings Regarding Januvia

Recent reports in the JAMA Internal Medicine indicate that patients taking Januvia are at a higher risk of developing pancreatitis when compared with those taking other Type 2 diabetic drugs which do not contain sitaglipin. The JAMA journal found that those suffering from pancreatitis who were hospitalized were twice as likely to have been taking Januvia.  Januvia is an oral anti-hyperglycemic belonging to a class of drugs known as incretin mimetics which stimulate the production of insulin.

The FDA is looking at all medications which fall under the category of incretin mimetics although the manufacturer of Januvia—Merck & Co.—remain staunch in declaring Januvia safe. In fact, despite a UCLA study which reports six times the risk of pancreatitis and 2.9 times the risk of pancreatic cancer among Januvia users, Merck claims there is “no compelling evidence of a causal relationship between Januvia and pancreatitis or pancreatic cancer.” Other studies have also found an increased risk of pancreatitis, pancreatic cancer and thyroid cancer among Januvia users.

Between 2006 when the FDA approved Januvia and 2009, there were 88 adverse reports from those taking Januvia. All 88 developed pancreatitis, 66 with symptoms so severe they were admitted to the hospital. Nineteen of those 88 developed pancreatitis within a month of beginning Januvia and over half of the patient’s symptoms subsided when Januvia was discontinued.

The Januvia FDA stance is that they have drawn no conclusions as to whether Januvia causes or contributes to the development of pancreatic cancer. The FDA is currently advising patients to continue to take their medicine as directed until they have spoken with their doctor despite conceding there could be risks associated with sitaglipin drugs. Past investigations into alleged “bad” drugs have rarely resulted in drastic changes, and even though the FDA required Merck to increase warnings on their labeling in 2009 and again in 2012, Merck still brought in over $3.3 billion dollars in Januvia sales in 2012.

As of yet, there is no Januvia recall on the horizon despite the studies showing a higher risk of serious pancreatic issues however the FDA did request that Merck & Co. conduct a safety study on rats in order to determine whether there was, in fact, a higher risk of pancreatitis or pancreatic cancer among Januvia users. This study was to be completed and submitted to the FDA by June 15, 2011, however by all accounts that study has yet to be submitted despite a warning letter in February, 2012 from the FDA to Merck. 

Merck is likely to face allegations of failure to warn and negligence as the lawsuits continue to mount. If you have taken Januvia and suffered a serious illness including pancreatitis, pancreatic cancer or thyroid cancer you should take steps to determine if you have a potential claim for your losses.

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