All Eyes On Avandia

Tuesday, July 13, 2010 - 3:34pm

Since it hit the market in 1999, diabetes drug Avandia has made millions for maker GlaxoSmithKline, but Food and Drug Administration advisors could soon vote to yank it off the market.

In 2007 Avandia was given a "black box" warning after studies found it increased the risk for heart problems, but a narrow vote from FDA advisors kept it on the market.

Now more recent studies are available for a new panel of advisors to review.

Coming to a conclusion depends on whose interpretation of the data they use.

GlaxoSmithKline researchers say diabetics need treatment options.

Independent researchers say the heart risks are too steep.

The panel has been asked to decide whether the drug should remain on the market with additional warnings, or be taken off completely.

The FDA is not required to follow the advice of the advisory committee.

Some experts say how the agency handles Wednesday's recommendation will define how it will treat future controversial drug decisions.
 

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