Tuesday, July 31, 2007

FDA Advisory Panel for Avandia Votes, Finds Heart Risk

Article in the Wall Street Journal -- Panel Keeps Avandia on Market: Glaxo's Diabetes Drug May Require Warning On Label for Heart Risks, by Anna Wilde Mathews.  Here's an excerpt:

A Food and Drug Administration advisory committee found that GlaxoSmithKline PLC's diabetes drug Avandia is tied to a risk of heart attacks, but it stopped short of voting to pull the medication off the market.

Several panel members said the drug should get a new heart-risk warning in its label, which would be a blow to the company but far less serious than a recommendation to end sales of Avandia. Last year, it was the company's second-biggest-selling drug with global sales of $3.38 billion, and it has been used by more than seven million patients world-wide.

The heart-risk warning is likely to accelerate the reshuffling of the growing market for diabetes drugs, boosting sales of older medications and Takeda Pharmaceutical Co.'s Actos, the only marketed rival that works the same way as Avandia. So far, Actos hasn't been linked to a heart-attack risk. The FDA doesn't have to follow the advice of its expert panels, but it typically does. An agency official said after the meeting that the FDA would aim to reach a decision quickly.



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