Parker McDonald Believes Merck Failed To Produce Safety Study Results Surrounding Diabetes Drugs Januvia and Janumet

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Based on a report by the FDA, Parker McDonald believes that Merck failed to produce safety study results.

A recent violation from Merck & Co. has come to the attention of Parker McDonald P.C., law firm located in Fort Worth, Texas. A report by the Food and Drug Administration (FDA) states that Merck has failed to comply with regulations that oversee their diabetes medications JANUVIA and JANUMET.

According to JANUVIA’s website, “JANUVIA is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type-2 diabetes.” The drug JANUMET combines JANUVIA with metformin to attempt to also lower blood sugar levels in adults.

Merck was notified by the FDA to perform post-market research on safety issues surrounding the two drugs. The FDA charged the pharmaceutical company to perform the studies after a number of complaints were filed about the drugs over a three year period. The complaints highlighted the development of acute pancreatitis.

The FDA proceeded to include the risk of pancreatitis in its prescription advisement and requested that Merck perform studies to dispute negative findings. The company agreed to complete the 3 month pancreatic safety study by March 15, 2011, but instead substituted it for a 12 month study done by an independent firm that was ultimately found inadequate.
The FDA could fine Merck up to $250,000 for its non-compliance, not including penalties. Merck had 30 days to submit a new study and six months to begin. Results from its research are still pending.

Information referred to in this release was reported by Anna Edney of Bloomberg.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business
or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

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Erin McDonald
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