GlaxoSmithKline Plc's widely used diabetes drug Avandia should be pulled off the market, U.S. Food and Drug Administration scientist David Graham said in a presentation prepared for delivery on Monday.
Graham, in slides prepared for his remarks to an advisory panel, said Avandia increases the risk of cardiovascular problems such as heart attacks while rival drug Actos, made by Takeda Pharmaceutical Co. Ltd., does not.
Senior FDA officials say they do not know if Avandia, known generically as rosiglitazone, increases heart-attack risk and are asking the advisory panel if the drug should come off the market or stay with stronger warnings or limits. Panel recommendations are expected on Monday afternoon.
Graham, a scientist in the FDA office that monitors the safety of medicines after approval, has been outspoken about drug risks and publicly criticized top FDA officials for failing to respond to warning signs with various medicines.
Glaxo said Avandia, which is used by millions of diabetics and had sales of more than $3 billion last year, was no more dangerous than other diabetes pills.
GSK continues to support Avandia as safe and effective when used appropriately, the drugmaker said in a statement summarizing its presentation to the FDA panel.