Avandia FDA Warnings

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In 2007, the FDA issued two separate national Avandia warnings to alert medical professionals and the public about the health risks associated with Avandia use.

What’s the problem?

Avandia became the center of controversy on May 21, 2007 when an analysis of several studies appeared as a headline article in the online version of the New England Journal of Medicine. The article revealed a significant increase in the risk of heart attack and other heart problems for patients taking Avandia.

On the same day, the FDA released an alert announcing the result of the analysis, and promised further investigation. The FDA eventually required a black box warning, its most serious level of warning, for the increased risk of coronary problems in patients taking Avandia.

Another 2007 study raised additional concerns about Avandia side effects. The study found that Avandia increases the risks of fractures of the upper arm, hand, and foot of women taking it and two other drugs manufactured by GSK, Avandamet, and Avandaryl. Since millions of people take the drug, bone deterioration could have a major health impact.

The FDA required GSK to prepare and release a new medication guide for Avandia, which was released on February 26, 2008. The new medication guide contains warnings on bone fractures, as well as of coronary side effects.

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