Avandia Warning: Avandia Side Effects and Risks

Avandia, GlaxoSmithKline’s (GSK) top-selling diabetes drug, 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 (NEJM). The new meta-analysis revealed a significant increase in the risk of heart attack and other heart problems for patients taking Avandia, raising concerns that heart attacks may be an Avandia side effect.

On the day the new analysis was released the FDA (Food and Drug Administration) released an FDA Alert announcing the results of the analysis, but also claiming that the results of long-term clinical trials conducted by GSK contradict the results in the NEJM article. The FDA did not recommend that physicians take their patients off Avandia at that time, but promised a further investigation. Seven Galson, the physician director of the FDA’s Center for Drug Evaluation and Research, announced that the FDA would analyze the information it has on the Avandia risk as soon as possible and make the results available. The FDA would also present the issue of Avandia’s potential heart attack side effect and the need for an Avandia warning or other action to an advisory committee as soon as one can be convened.

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.

The NEJM article  raises concerns about the FDA’s approval of Avandia: These emerging findings raise an important question about the appropriateness of the current regulatory pathways for the development of drugs to treat diabetes. The FDA considers demonstration of a sustained reduction in blood glucose levels with an acceptable safety profile adequate for approval of antidiabetic agents. However, the ultimate value of antidiabetic therapy is the reduction of the complications of diabetes, not improvement in a laboratory measure of glycemic control.

Members of Congress have also expressed concern about the FDA handling of Avandia. Both houses of Congress are currently debating funding bills for the FDA that contain certain requirements for reform of the methods used by the FDA to monitor drug safety. Representatives John Dongell and Bart Stupac, both Democrats from Michigan, have vowed to investigate further whether GSK revealed the dangers of Avandia to the public. The House Oversight Committee has announced a hearing on the FDA’s handling of Avandia scheduled for June 6, 2007.

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 this drug, bone deteriorization 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.

Check out the following articles for more information about Avandia, filing a Avandia lawsuit and finding a Avandia attorney.