The surprise announcement came in statements made by FDA commissioner Andrew C. Von Eschenbach, MD, before a U.S. House committee investigating whether the FDA failed to heed warnings of possible heart attack risks posed by Avandia.
The new black box warnings have nothing to do with heart attacks. The label will warn that the class of drugs to which both Actos and Avandia belong increase a person’s risk of congestive heart failure. The drugs current labels warn of this risk, but the new warning will be far more prominent.
The recent firestorm over Avandia concerns evidence suggesting - but by no means proving -- that Avandia may increase the already high risk of heart attacks in people with diabetes. GlaxoSmithKline points to studies that show no clear increased risk of heart attack in patients taking Avandia. However, editorials in this week's issue of The New England Journal of Medicine warn that the jury is still out and that Avandia may pose a heart attack danger.
In testimony before the House committee, GSK research and development chair Moncef Slaoui, PhD, defended Avandia's heart safety.
"Avandia, when compared to other widely used antidiabetes medicines, is not associated with an increased risk of death, including death from a cardiovascular event," Slaoui said in a prepared statement.
Actos has not been linked to any increased risk of heart attack.
"Takeda remains confident in the safety and efficacy of Actos when used according to its label, and with this revision, we can heighten patient and physician awareness of an already known but serious side effect," Takeda senior medical director Robert Spanheimer, MD, says in a news release.