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 [1] 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 [2], 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 [3]/not causing [4] heart attacks. The only ray of hope for the GlaxoSmithKline drug lies in a reassessment [4] 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 [5]
- read the report [6] from The Times
- and check out the WSJ report [7] (sub. req.)
Related Articles:
What to do with Avandia sales force? Report [8]
Expert committee says Avandia should stay. Report [9]
FDA expert wants Avandia withdrawn. Report [3]
Docs shunning Avandia in wake of safety study. Report [2]
Links:
[1] http://www.fiercebiotech.com/story/avandia-risks-exposed-under-deal-to-post-data/2007-05-23
[2] http://www.fiercebiotech.com/story/docs-shunning-avandia-in-wake-of-safety-study/2007-05-29
[3] http://www.fiercebiotech.com/story/fda-expert-wants-avandia-withdrawn/2007-07-30
[4] http://www.fiercepharma.com/story/new-study-casts-doubt-avandia-dangers/2007-08-10
[5] http://www.fiercebiotech.com/press-releases/press-release-manufacturers-some-diabetes-drugs-strengthen-warning-heart-failure-risk
[6] http://business.timesonline.co.uk/tol/business/industry_sectors/health/article2262604.ece
[7] http://blogs.wsj.com/health/2007/08/15/new-avandia-warning-but-not-the-one-you-think/
[8] http://www.fiercepharma.com/story/what-do-avandia-sales-force/2007-08-14
[9] http://www.fiercebiotech.com/story/expert-committee-says-avandia-should-stay/2007-07-31