The black-box wait is almost over [1]. Within days, Avandia's label will get its new heart-attack warning, the FDA says, ending months of suspense.
What will it say? That's not yet clear, but during negotiations with the FDA, GlaxoSmithKline CEO Jean-Pierre Garnier (photo [2]) said it wasn't the black box itself that concerned him, but the warning's actual wording. According to news reports, Garnier told the Reuters Health Summit in New York that he actually expects Avandia sales to rebound once the FDA's decision is handed down.
You'll recall that Canadian regulators warned doctors just this week [3] that heart failure patients shouldn't take Avandia at all, and they restricted use of the drug in other patients.
- see this report [4]
- read about GSK's stock [5] reacted to Garnier's comments in the Houston Chronicle
Related Articles:
Avandia cleared FDA by one vote. Report [6]
Avandia, Actos don't boost death risk. Report [7]
FDA adds to drumbeat of bad news for Avandia. Report [1]
Expert committee says Avandia should stay. Report [8]
Links:
[1] http://www.fiercepharma.com/story/fda-adds-to-drumbeat-of-bad-news-for-avandia/2007-08-15?utm_medium=nl&utm_source=link
[2] http://www.fiercebiotech.com/pages/outgoing-glaxosmithkline-ceo-jean-pierre-garnier
[3] http://www.fiercepharma.com/story/canadians-warn-patients-against-avandia/2007-11-12
[4] http://www.newsinferno.com/archives/2026
[5] http://www.chron.com/disp/story.mpl/ap/fn/5298465.html
[6] http://www.fiercepharma.com/story/spotlight-avandia-cleared-fda-one-vote/2007-10-30
[7] http://www.fiercepharma.com/story/avandia-actos-dont-boost-death-risk/2007-09-28
[8] http://www.fiercebiotech.com/story/expert-committee-says-avandia-should-stay/2007-07-31