07/30/2007 - One of the US FDA's scientists has called for GlaxoSmithKline's diabetes drug Avandia to pulled off the market because of the risk of heart disease.
In a presentation to the FDA, David Graham said Avandia increases the risk of cardiovascular problems whereas while a rival drug, Actos, made by Takeda of Japan has no such complications.
Avandia sales have plummeted since May when US researchers, writing in the New England Journal of Medicine, said the drug increased the risk of heart death by 64% and the risk of heart attack by 43%. Avandia sales dropped by 22%, to £349m, in the last quarter.
The FDA has asked its advisory panel to consider whether the drug should be withdrawn from the US or if it should be allowed but with stronger labeling or limits on its use. A recommendation by the advisory panel is expected in the US this afternoon and is usually rubber-stamped by the FDA.
Glaxo claims that Avandia, which notched sales of more than $3bn last year, is no more dangerous than other diabetes pills. "GSK continues to support Avandia as safe and effective when used appropriately," it said in a statement.
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