The FDA has issued a formal warning letter to Merck for being months late on two post-market study deadlines to assess acute pancreatic damage risk associated with the diabetes drugs Janumet and Januvia. Januvia (sitagliptin) is a medication approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors, Janumet combines Januvia with metaformin.
The FDA required Merck perform additional testing following increasing concerns over a Januvia pancreatitis over risk three years ago. Merck broke its promise to conduct the three-month pancreatic safety study after the FDA expanded approvals for Januvia and Janumet. The study was due to be completed by March 15, 2011, and a final report should have been presented to the FDA by June 15, 2011. It was not.
One Januvia pancreatic cancer study in 2011 did find indications that the drug may increase the risk of pancreatitis and pancreatic cancer.
The FDA warning appears to be the first time the FDA has invoked its new enforcement authority for postmarking requirements granted under the 2007 FDA Amendments Act. Violations of this obligation can result in charges of mislabeling, and in fines of $250,000 and potentially more if they continue. As a dangerous medication attorney, I am pleased that this may signal a new trend at the agency for holding manufacturers more accountable.
Our Januvia and Janumet claims lawyers advise that if you are taking one of these medications to discuss the risks and benefits with your prescribing doctor. We encourage you to report any adverse events you may have on this medication directly to the FDA. You may also be entitled to make a claim against Merck. Please our contact our Miami Beach personal injury law firm to discuss your legal rights.