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

By Amanda Gardner
HealthDay Reporter

WEDNESDAY, July 14 (HealthDay News) -- The controversial diabetes drug Avandia does raise the risk of heart attack more than other medications of its kind but should stay on the market with tightened controls, a U.S. government advisory panel recommended late Wednesday.

By a complex series of votes, the 33-member panel of experts rejected the option that the U.S. Food and Drug Administration remove Avandia from the market for safety reasons.

The series of votes started, according to the New York Times, with 18 members of the panel voting that Avandia might up the risk of heart attack, six saying they weren't concerned about a raised risk, and nine saying they were unsure.

On their second vote, however, only one member of the committee thought that Avandia increases the risk of death when compared with older medicines, 20 said it did not increase the risk of death, and 12 remained unsure.

The panel seemed more decided when comparing Avandia's safety risks to its sister medication, Actos. Twenty panel members voted that Avandia was more likely to cause heart attack than Actos, four voted that it was no more likely to do so, and eight said they didn't know, the Associated Press reported.

And on the key vote, the decision on Avandia's future, 12 members voted for pulling the drug, 17 voted for new warning label revisions or restrictions on use, and three voted that no changes were needed.

"I don't think there's any question that the use of the drug will decrease and that both physicians and patients will look at the warning very carefully before prescribing Avandia, although that assumes that the final FDA ruling will follow the panel's recommendation," said Dr. Alan Kadish, president and CEO of Touro College, after the votes.

The outcome, he added, was not a surprise. "I expected the vote to be split, and it was split in even more comp
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Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
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