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Home / Januvia® Study on Pancreatitis

Januvia® Study on Pancreatitis

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The US Food and Drug Administration has sent a warning letter to Merck Sharp and Dohme Corp. (“Merck”) citing a violation of FDC Act § 505(o)(3). This type of warning letter, dated February 17, 2012, is part of the FDA’s new enforcement provisions recently granted by Congress.

The issue concerns the diabetes drugs Januvia® and Janumet® (sitagliptin). Januvia® and Janumet® help lower blood sugar levels in people who have type 2 diabetes. The FDA approved Januvia® in 2006. There have been reports of pancreatitis associated with the use of sitagliptin in FDA’s Adverse Event Reporting System database. Pancreatitis can be deadly if it is not treated. As a result of these reports, Merck previously agreed to do a post-approval study of the drugs in mice to see if they increase the risk of acute pancreatitis.

Merck was supposed to submit its study design to the FDA by June 15, 2010. The final report was supposed to be submitted by June 15, 2011. On Tuesday, Merck promised to submit a final study design to the FDA within 30 days of receipt of the FDA letter. They said that they would begin the study within six months.

The FDA occasionally requires companies to conduct further post-marketing trials of a drug after it is approved to resolve any uncertainty about safety. There is not yet a confirmed correlation between taking Januvia® (sitagliptin) and pancreatitis. But, further study could show a connection. If a company that fails to comply with the FDA warning letter, it could be fined up to $250,000.

Januvia® and Janumet® had combined sales of $4.7 billion for 2011, up 40% from the year before.

If you or a loved one has taken a prescription drug and you believe you have been injured, we may be able to help you. Please call us at Longo Legal, PLLC to speak with a knowledgeable lawyer at 855-566-4648.

Source: FDA may fine Merck for lack of study on diabetes drugs, Reuters, February 29, 2012.

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