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Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
Date:7/15/2010

lex ways than one might have imagined. The panel did the best they could with data that weren't completely conclusive, that suggested an increased risk but didn't make it clear how much that increased risk was," he said.

And he explained, "The majority of the panel didn't feel the increased risk was enough to summarily remove a drug that hundreds of thousands of people are taking successfully."

A second heart expert agreed.

"I didn't think that the evidence was yet compelling enough to withdraw the product from the market," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City. "It sounds like they're going to add some new warnings regarding the risk, and that seems like an appropriate step."

And such a step will likely decrease the use of Avandia, anyway, Garratt added. "Use went down pretty sharply after criticism started to fly and the presence of new boxed warnings will further depress the prevalence of this product in the marketplace," he said.

But Garratt also said he didn't think the experts' votes would end the controversy over Avandia.

"There is so much dissent within the FDA about the appropriate action to take with this drug that I can't imagine this will be the final world," he said. "Also, we've got an alternative product [Actos] that seems to be essentially as effective at controlling diabetes but hasn't been linked to the cardiovascular risks."

In a statement released after the vote, Dr. Ellen Strahlman, chief medical officer at GlaxoSmithKline, which makes Avandia, said, "Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients ... Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine."

The FDA committee had been meeting intensively since early Tuesday morning, hearing di
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Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
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