Avandia Black Box Heart Attack Warning Finally ApprovedNov 14, 2007 | Parker Waichman LLP
Avandia will finally bear a new black box warning about heart attack risks associated with the controversial diabetes drug, the Food & Drug Administration (FDA) announced today. The black box warning had been sought by patient advocates ever since Avandia was linked to an increased risk of heart attacks earlier this year. The FDA aid that Avandia’s maker, GlaxoSmithKline, had also agreed to conduct a large scale clinical trial of heart attack risks associated with Avandia.
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. On August 14, the FDA had upgraded the Avandia label to include a warning about congestive heart failure.
According to the FDA press release announcing the Avandia heart attack black box warning, the new caution would include the following statement: “A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.” The FDA also said that Glaxo was working on new medical guide for Avandia patients.
Avandia was Glaxo’s number two selling drug prior to the May heart attack revelations. Since the Cleveland Clinic study was published, sales have dropped 48 percent. Some large insurers, including the Department of Veterans Affairs, have dropped Avandia from their prescription drug formularies. 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.