British Regulators Want Avandia Yanked - Drug Discovery and Development

LONDON (AP) – GlaxoSmithKline’s controversial diabetes pill Avandia should be pulled from the U.K. market because of concerns that the drug can increase the risk of heart attacks, British drug regulators said.

The Medicines and Healthcare products Regulatory Agency (MHRA) said an independent panel of experts had advised it that the risks of Avandia outweigh its benefits, and that the drug should no longer be sold in Britain. The body said it had sent a letter to doctors in July advising them to consider alternative treatments.

The British Medical Journal also called for the immediate withdrawal of the drug, saying it should never have been licensed in the first place.

Avandia was approved by the European Medicines Agency in 2000 to help lower blood sugar levels in patients with type 2 diabetes. The drug is currently under review in Europe and the U.S., and European regulators are scheduled to meet Wednesday to decide Avandia’s future.

GSK maintained that its extensive research involving over 50,000 patients has showed that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes drugs.

“We continue to believe that Avandia is safe and effective when it is prescribed appropriately,” the London-based company said in a statement.

But the British Medical Journal was critical of both GSK’s research methods and the European approval process, outlining what were described as multiple problems associated with Avandia’s safety in a report published Monday.

In the U.S., the Food and Drug Administration has placed Avandia under scrutiny since 2007, when a study suggested that patients taking the drug were 43 percent more likely to experience heart attack than those taking other diabetes drugs or no diabetes medication.