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FDA Warning Letter Addressed to Merck Suggests Misbranding of Diabetes Medications

According to a U.S. Food and Drug Administration (FDA) warning letter issued on Tuesday, Merck & Co. is being held liable for the transgressions allegedly committed during a distinct post-market study. Merck failed to comply with the milestone dates, within a previously agreed-upon timetable for completion, to conduct a required post-marketing study (PMR) for the purpose of investigating a safety issue associated with the use of Januvia and Janumet under New Drug Applications (NDA) 021995 and 022044, respectively. The negligence demonstrated on Merck’s behalf is in direct violation of the Federal Food, Drug, and Cosmetic Act and may result in future penalties.

Januvia is a once-daily medication that is intended to help lower blood sugar levels in adults diagnosed with type 2 diabetes. The diabetes medication boasts the ability to increase the insulin made by the pancreas when blood sugar is high and reduce the amount of sugar made by the liver.

Similar to that of Januvia, Janumet is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Janumet works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. The diabetes medication also helps to regulate the levels of insulin the body produces after eating.

Unfortunately, an FDA warning letter recently posted on their website acknowledged that these diabetes medications are to be considered misbranded due to Mercks neglect to comply with a three month pancreatic safety study in rodents that was previously agreed upon. Subsequently, Merck agreed to the study to gain expanded approval of the drugs and committed to completing it by March 15, 2011. By not completing said study, Merck practices, or therefore lack of, are in direct violation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act

According to the letter, “this violation is concerning from a public health perspective,” because the additional testing is to assess “a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with sitagliptin,” the main ingredient in both medicines.

Mercks failure to comply with the approved timetable and periodic report submissions agreed upon with the FDA violated the established post-marketing requirements for these medications. Furthermore, Merck failed to show good cause for not conducting the additional testing required to further assess whether a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with the use of sitagliptin, represents a public health risk.

The letter acknowledges that Merck may potentially face regulatory actions by the FDA without further notice. Included in future actions may be the acquisition of financial assets, otherwise known as a civil money penalty. Each violation committed by Merck could face maximum penalty of $250,000.

Do I Have a Januvia and/or Janumet Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Januvia and/or Janumet lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by Januvia and/or Janumet, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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