FDA wants GSK to add more health warnings on diabetese drug Avandia
15 Jul 2010
The UK's biggest drug company GlaxoSmithKline (GSK) got a reprieve after the US Food and Drug Administration (FDA) advisory panel stopped short of removing its blockbuster diabetic drug Avandia from the US market, imposing additional heart risk warnings.
After hearing two days of contradictory facts whether Avandia poses a risk or not to the heart, 20 of the 33 members of the FDA advisory committee voted to keep Avandia on the market, while 12 voted against it and 1 abstained.
But, seven panel members called for stronger warnings on the drug's label, while 10 asked for sterner language and tighter restrictions on its use. Three members said no changes were required at all.
GSK narrowly escaped in sharp contrast to a 2007 recommendations of a FDA advisory panel, where only 1 of the 23 panel members voted to pull Avandia from the market.
Yesterday's result showed that there is a rising concern that Avandia does have serious side effects but the last say on whether to pull the drug from the market or not is with the FDA, which now will have to act on the panel's decision.
The FDA can take a decision on its own and is not obliged to go by the advisory panel recommendations, though often than not, its rulings are in line with the panel's recommendation.
