FDA adds to drumbeat of bad news for Avandia

Hang the black crepe: the FDA has ordered new "black box" warning labels for Avandia and its Japanese cousin Actos. The warnings emphasize that the diabetes drugs may trigger heart failure and that doctors should closely monitor patients taking them.

The decision is yet another drumbeat of bad news in what's becoming a long, slow dirge. It comes on the heels of a 40 percent decline in sales, which could be weighted down even more by the black-box label. And the new labeling on heart failure is a separate issue from the controversy about Avandia causing/not causing heart attacks. The only ray of hope for the GlaxoSmithKline drug lies in a reassessment of the heart-attack risk data; the FDA says it will continue to review the drug and update doctors in a few weeks.

- see the FDA announcement
- read the report from The Times
- and check out the WSJ report (sub. req.)

Related Articles:
What to do with Avandia sales force? Report
Expert committee says Avandia should stay. Report
FDA expert wants Avandia withdrawn. Report
Docs shunning Avandia in wake of safety study. Report

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