Merck Failure to Conduct Januvia Pancreatitis Study

Merck Failed To Conduct A Safety Study. The U.S. Food & Drug Administration has hit Merck & Co. with a warning letter for its failure to conduct a safety study of its type 2 diabetes drug, Januvia. The study, which was to be conducted with rodents, was meant to assess Januvia’s association with pancreatitis.

Januvia’s label already warns that acute pancreatitis is a possible side effect of the drug, In the warning letter, the FDA says that it informed ‘Merck’ in 2009 was required to conduct a three-month pancreatic safety study in a diabetic-rodent model treated with sitagliptin, the active ingredient in Januvia.

The requirement was included by the FDA as part of its February 2010 approval of supplemental new-drug applications for Januvia and Janumet, another sitagliptin-containing medication made by Merck.

The FDA said the Submission didn’t Meet its Requirements

While Merck submitted data from an independent, 12-month study in mice, the FDA said the submission didn’t meet its requirements, and ordered the three month study.  A study proposed by Merck was found to be deficient by the FDA.

The study was “part of a written agreement between you and the FDA to conduct additional testing to further assess a signal of a serious risk of acute pancreatitis…associated with the use” of Januvia, the warning letter states.

The FDA warning letter gives the drug maker 30 days to submit a final study design within 30 days to address the requirement.

According to a report from The Wall Street Journal, Merck issued a statement on its website stating it would submit a final protocol for the required study to the FDA within 30 days and will start the study within six months.

Need Legal Help Regarding Merck?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).