Avandia could soon bear a long-awaited black box warning about its potential to cause heart attacks, as media outlets are reporting that a Food & Drug Administration (FDA) decision on the warning’s wording could be handed down in days. If true, the new black box warning would be announced just after the CEO of GlaxoSmithKline boasted that Avandia sales could rebound depending on the wording of the heart attack warning.
Avandia already bears a black box warning – the FDA’s strictest caution – regarding its relationship to congestive heart failure. The FDA has been considering an additional heart attack black box warning for Avandia since July, after an advisory panel recommended the new cautions. That same panel had voted to allow Avandia to remain on the market, even though it agreed that there was evidence that the diabetes drug did in fact increase heart attack risk. 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. Since then, sales of the drug – once a best seller for Glaxo – have fallen by more than 48 percent following the revelations.
But Glaxo CEO Jean-Pierre Garnier told Reuters that the new Avandia black box heart attack warning was not necessarily bad news for the drug or the company. In fact, Garnier said that he expected Avandia sales to rebound, depending on the black box’s wording. “It’s not the black box that matters or the lack of black box, that’s not important to me; it’s — what is it saying?” Garnier told the Reuters Health Summit in New York.
Last month, Glaxo confirmed that it was “negotiating” with the FDA over the wording for a black box warning for heart attack risk. Given the FDA’s prior conduct in relation to Avandia’s safety issues, Garnier’s words will likely not comfort many patient safety advocates. Over the summer, Glaxo 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. Given that track record, it is possible to read quite a bit into Garnier’s optimism over Avandia sales.
Exactly what Garnier’s statements indicated could become apparent in the next few days. Dr. Janet Woodcock, the FDA’s deputy commissioner for operations, confirmed to Reuters that the agency’s internal Drug Safety Oversight Board had delivered a recommendation to her office but declined to reveal its contents. According to Woodcock, an announcement regarding the new Avandia black box warning could come any day.