EU pulls plug on Glaxo’s Avandia, FDA restricts

European regulators said on Thursday GlaxoSmithKline’s diabetes drug Avandia should be taken off the market but U.S. officials allowed it to stay, with significant restrictions due to concerns about heart risks.

In separate but coordinated statements, the U.S. Food and Drug Administration in Washington and the European Medicines Agency (EMA) in London said they agreed on the risks associated with the drug but had reached different conclusions on action.

Avandia was once Glaxo’s second-biggest seller but sales have tumbled in recent years and Glaxo said it expected minimal sales in future.

Both Avandia, known generically as rosiglitazone, and its main rival drug Actos, or pioglitazone, made by Takeda Pharmaceutical, are known to raise the risk of heart failure.

But Avandia has also been linked to an increased risk of heart attacks, following publication of a study in 2007 by Dr. Steve Nissen of the U.S. Cleveland Clinic, whose findings prompted the latest safety reviews by regulators.

U.S. health advisers recommended to the FDA in July that Avandia be allowed to stay on the market but with additional warnings on its label.

But some European government safety experts, including those in Britain, argued that the risks of Avandia outweigh its benefits and the drug should be pulled from the market.

Glaxo argues that extensive research has shown Avandia, known generically as rosiglitazone, to be safe and effective when used according to the label.

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By Kate Kelland and Ben Hirschler

LONDON (Reuters)