Avandia’s Warning Gets Strengthened, Again

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November 15th, 2007

"Heart Attack Risk Warning for Avandia"

At the urging of the Food and Drug Administration, GlaxoSmithKline is adding a new warning to its once-popular diabetes drug Avandia . An increased risk of heart attack will now appear in addition to heart failure in Avandia's existing “black box” warning.

Journal Article Causes Concern

The safety of Avandia came under scrutiny in May when Cleveland Clinic cardiologist Dr. Steven Nissen published an article in a medical journal suggesting that the drug increased the risk of heart attack by as much as 30 to 40 percent.

Nissen's findings did not apply to Actos, a similar diabetes drug and sales of Avandia suffered as a result. However, both Avandia and Actos currently carry a black box warning, the strongest type, about the risk of heart failure .

On the Market Despite Risks

FDA officials considered removing Avandia from the market, but an internal safety-board voted 8-7 in favor of continuing U.S. sales of the drug and an outside advisory panel also recommended its continued sales.

The agency has asked Glaxo to conduct an extensive study to provide more conclusive answers regarding Avandia's risks. Final results of the study are not expected until 2014, though Glaxo will have to provide findings periodically.

(Source: The Wall Street Journal online)

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