That’s what the FDA is proposing for the diabetes drugs. Two weeks ago, the FDA sent letters to Glaxo and Takeda, which sells Actos, saying the risk of heart failure posed by these meds warrants black box warnings.

“FDA decided to make this request because, despite the existing warnings, these drugs were being prescribed to patients with significant heart failure,” FDA commish Andy von Eschenbach said during testimony at the Avandia hearing earlier today. And he maintained that the decision was made by senior FDA staff at an internal regulatory briefing in April, before Steve Nissen’s controverisal meta-analysis was published on May 21 in the New England Journal of Medicine.

“Although this issue is already prominent in the warnings section (on the labeling) for both drugs, FDA decided to make this request because, despite the existing warnings, these drugs were being prescribed to patients with significant heart failure.”

Of course, the agency could’ve acted before May 21, but didn’t do so until after the NEJM analysis was published. What takes them so long?

And by the way, Andy acknowledges that Glaxo’s phase IV, or post-marketing study, which was called Adopt, “was not specifically designed for heart attacks in and of itself.”