FDA Committee Delivers Split Verdict on the Diabetes Drug Avandia

Avandia, which was put on the market in 1999, is also known as rosiglitazone. Avandia is a drug taken once or twice daily to manage type 2 diabetes. It is prescribed to those who need more than one medicine to help treat their diabetes in different ways.

Most of the committee members voted to leave Avandia on the market but recommended that changes be made in how it is prescribed. Additionally, 12 out of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven voted to add stiffer warnings to the current label, and 10 wanted both stiffer language and restrictions on its use.

A 2007 study, published in the New England Journal of Medicine, linked the drug to a 43 percent higher chance of heart attack as well as in increased risk of stroke and, in some cases, death. After that, federal regulators mandated that GlaxoSmithKline (GSK) add more warnings to the drug’s labeling.

GSK is facing more than 13,000 legal challenges, and has already awarded $60 million to settle some of them. A Philadelphia court will hear the first American cases in October.

If you or a loved one has suffered adverse side effects as a result of taking Avandia and other defective drugs, click here to locate a personal injury lawyer in your area. If a loved one has died as a result of taking a defective drug, a wrongful death lawyer can guide you through the process of filing a wrongful death lawsuit.

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