FDA Panel Backs Easing Diabetes Treatment Restrictions

By Rheingold Giuffra Ruffo & Plotkin LLP

By: Caroline Mason

An FDA panel recently voted in favor of easing the use restrictions on diabetes treatment, Avandia, that were placed on it in 2010. It was emphasized that when re-analyzed, previous heart-safety risk warnings may have been overstated.

13 out of 26 panelists voted in favor of removing limitations, which was favorable for GlaxoSmithKline’s controversial diabetes treatment. Over a decade ago, this was the “best-selling diabetes drug in the world.” These restrictions were placed on the drug in 2010 after critics said the industry-sponsored trial was flawed. A study by Cleveland Clinic suggested that patients using Avandia had a 43 percent higher risk for heart attack. EU regulators pulled Avandia off the market at that time.

The Center for Drug Evaluation and Research has not come to a final decision on whether they will be removing use limitations or not, but it is unlikely that prospects will be improved for Avandia.

After the Cleveland study GSK had more than 10,000 lawsuits claiming that the company did not warn them about the risks associated with Avandia. Although the company settled some of the claims, many are left unsettled and the company has paid $3 million to settle other cases.

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