Avandia is drawing more fire, this time from U.K. regulators. British watchdogs have called on European Medicines Agency to yank the diabetes medicine off the market completely. The move was reported by the British Medical Journal, which piled on with its own demands for withdrawal, saying that the GlaxoSmithKline drug should never have been approved to begin with.
GSK is defending the drug--and its clinical data on it--saying that it's studied Avandia's safety in more than 50,000 patients. A spokesman tells the Daily Mail that GSK "completely stands by the drug." Bristling at the BMJ's suggestion that it kept data to itself, the company says in a statement, "We have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner." Acknowledging the safety reviews now under way at the FDA and EMA, the company says it will "continue to work with regulatory authorities worldwide in the best interest of patients."
Both the EMA and FDA are poised to decide how to proceed with Avandia. As the Financial Times reports, the EMA's Commission on Human Medicines determined in July that the drug should be withdrawn. Now we know the U.K. has weighed in with another vote for withdrawal; recommendations from Germany and Sweden are due soon. The FDA's advisory panel turned in a mixed vote, with some votes for withdrawal and others for increased warnings and/or restrictions on the drug. Decisions from both should come this month.