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

ffering opinions not only from outside experts and pharmaceutical representatives but also from within the FDA itself.

The safety of the blood-sugar-lowering drug, part of the thiazolidinedione family, has been in question for years.

In 2005, the FDA asked Glaxo to conduct a meta-analysis of all its clinical trials on the drug.

The analysis, which did show a signal of increased risk of heart attack, was submitted to the FDA the following year.

FDA then did its own analysis while a number of other trials came out also showing signals of heart troubles.

In November of 2007, FDA added a boxed warning to the drug saying that there was a potential risk of increased cardiovascular ischemic events with Avandia.

The expert panel focused much of its attention on the results of the highly publicized RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes), announced in June of 2009. The trial found that Avandia significantly raises the risk of heart failure (and bone fractures) though not cardiovascular disease or death.

Both Avandia and Actos, which is made by Takeda, came with warnings regarding heart failure when they were first approved.

The drama intensified considerably just before the advisory meeting began. Last Friday, an FDA official posted statements on the agency's web site questioning the design and interpretation of the pivotal RECORD trial.

Then in a report released early Tuesday, the Times said that GSK knew more than a decade ago that Avandia caused an increased risk of heart problems but covered up the information.

Glaxo, in a prepared statement, said that, "The RECORD study was conducted according to good clinical practices and the data are reliable. . . RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to [diabetes drugs] metformin and sulfonylur
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Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
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