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Avandia Black Box Warning on Heart Attack Risk Could Soon Be a Reality

Oct 24, 2007 | Parker Waichman LLP

An Avandia black box warning about its potential to cause heart attacks could soon appear on the drug’s label if officials at the Food & Drug Administration (FDA) have their way.  The FDA is said to be pushing hard for the black box warning, the FDA’s strictest, to be including on Avandia’s label regarding the heart attack risks associated with the controversial diabetes drug.  Avandia already carries a warning about heart failure risks, but a new black box heart attack warning would be far more serious.

Avandia has been a subject of debate since May 21, 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.   Since the Cleveland Clinic study was published, a great deal of controversy has swirled around Avandia.  In June, Congress held hearings to discuss Avandia and the FDA’s handling of its safety issues.  At those hearings, it was revealed that GaxoSmithKline, Avandia’s manufacturer, had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.  Since those revelations were made public, the FDA has been under a great deal of pressure to take action on Avandia.

 In July, the FDA convened a panel to discuss the issues surrounding Avandia’s heart attack risk.  The panel voted 20-3 that the drug did in fact raise the chance of heart attacks, yet the panel still voted 22-1 to allow it to remain on the market.  They recommended that Avandia be given a warning label about the cardiac problems.

If labeling changes are adopted, the new Avandia black box warning would focus on the drug’s risk of ischemic heart problems, or events in which blood is unable to reach the heart.  The FDA’s own analysis of various Avandia studies had found that the drug carries a 38% higher risk of causing such problems.  For its part, GlaxoSmithKline continues to insist that Avandia poses no more risk than other diabetes drugs, and that other studies have shown it to be safe.  

The addition of a black box warning on Avandia could be a further drag on sales of the drug, which have dropped more than 60% since the release of the Cleveland Clinic study.  Just last week, the Department of Veterans Affairs (VA) announced that it was removing Avandia from its prescription drug formulary.  The VA said that it would still make Avandia available for patients who were taking it now and wanted to continue.  But the decision means that patients not currently prescribed Avandia will not be able to get it through the VA in the future.  Right now, the VA accounts for about 8% of Avandia sales.

GlaxoSmithKline has acknowledged that it is working with the FDA to formulate a new warning label for Avandia.  The FDA will make the new Avandia black box warning public once it is finalized.


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