Avandia Controversy Won't Go Away with New Heart Attack Black Box WarningNov 15, 2007 | Parker Waichman LLP
Avandia is getting yet another break from the Food & Drug Administration (FDA). While the FDA did announce the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks, it is not the strongly worded warning that many patient advocates had call for. But that should surprise no one, as it simply repeats the FDA’s past pattern of turning a blind eye to Avandia safety problems.
Avandia’s heart attack link has been a subject of concern since May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. Over the summer, GlaxoSmithKline, the maker of Avandia, and the FDA came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. Testimony at a congressional hearing in June revealed that the company and the FDA had known about the heart attack risk as far back as September 2005. That congressional investigation also uncovered allegations that in 2005, an FDA scientist who had advocated for a strong black box warning on Avandia about its risk for congestive heart failure had been removed from an Avandia safety review.
Now comes this weakly worded heart attack warning. While the new black box mentions the Cleveland Clinic heart attack study, it also says that the Avandia – heart attack link is “inconclusive”. In comparison, Canada’s regulatory agency issued a much stronger Avandia warning last week. Under the direction of Health Canada, Glaxo sent a letter to Canadian health professionals informing them that Avandia can no longer be prescribed as monotherapy for type 2 diabetes, except when metformin use is contraindicated or not tolerated. Health Canada has also withdrawn its approval for Avandia to be used in combination with a sulfonylurea, except when metformin is contraindicated or not tolerated. Finally, the letter said that treatment with Avandia is now is now contraindicated in patients with any stage of heart failure.
While many Avandia critics in the US were hoping for the FDA to take action similar to that of Health Canada, the new wording of the black box warning is not suprising. Last month, Glaxo confirmed that it was “negotiating” with the FDA over the wording for a black box warning for heart attack risk, so obviously the company had a lot to say about the warning’s make-up. And just one day before the Avandia black box warning was announced, Glaxo’s CEO told Reuters news agency that he thought Avandia sales would rebound as long as the black box warning wasn’t too strong.
In announcing the new black box warning, the FDA did say that it was requiring Glaxo to perform more clinical trials on Avandia’s heart attack risks. But once again, Glaxo will be paying for and supervising those Avandia trials, so there’s no telling how thorough they’ll be. Obviously, the new black box heart attack warning will not mean the end of the Avandia controversy.