Secret FDA Avandia Vote Outrages Senator--Begs Questions on Procedure

October 31, 2007, New York, NY— A high-ranking Republican Senator has learned that an internal panel of government safety experts recently voted in a private meeting to keep Type 2 diabetes drug Avandia on the market by a sliver-thin margin of 8-7. Sen. Charles Grassley of Iowa wants answers to why the Food and Drug Administration’s Drug Safety Oversight Board (DSOB) did not disclose this vote to the public, which took place on October 2, 2007, according to Reuters.

“This is yet another example of how patients are kept in the dark about how close a pharmaceutical comes to being withdrawn from the market,” said Arthur Luxenberg, partner of personal injury law firm Weitz & Luxenberg, P.C. “Both the FDA and GlaxoSmithKline had an obligation to fully inform the public of Avandia’s heart risks. There are growing questions about who knew what and when.”

The public at large only learned of Avandia’s link to a significant increase in the risk of heart attack in June 2007, after the New England Journal of Medicine published that finding in a combined analysis of more than 40 studies.

Following that report, the FDA announced in June that the toughest so-called “black-box warning” label would be placed on Avandia for its link to heart failure. This move was overshadowed, however, by the discovery that FDA safety reviewers reportedly recommended taking that urgent step more than a year earlier. The FDA is currently weighing whether to add a separate warning label for heart attack, according to the Wall Street Journal. This label would hobble GlaxoSmithKline’s contention that Avandia is just as safe as its competitors. Its leading drug rival, Actos, does not have a warning for heart-attack risk.

If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of a knowledgeable drug attorney. Get a free case review by filling out the form below.

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