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GSK's Avandia study halted by FDA

The US Food and Drug Administration has asked GlaxoSmithKline to suspend enrolment in a postmarketing study of diabetes drug Avandia

The US Food and Drug Administration (FDA) has asked GlaxoSmithKline (GSK) to suspend enrolment in a post-marketing clinical study of the company's controversial diabetes drug Avandia (rosiglitazone).

The FDA's "partial clinical hold" suspends enrolment of new patients in the trial while the federal agency reviews the recommendations made by outside experts last week during a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Patients who have already been enrolled will continue in the study.

The trial, called Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE), is designed to compare the cardiovascular safety of Avandia with Takeda's diabetes drug Actos (pioglitazone hydrochlorid). At the advisory committee meeting, panel members voted 21-to-four that Avandia is more likely than Actos to cause a heart attack. 

"GSK will work with the TIDE Steering Committee to send a summary of recent safety data and a summary of the FDA Advisory Committee meeting on Avandia to all TIDE investigators and Institutional Review Boards to ensure they have the latest information for patients," the company said.

The panel members voted last week 19-to-11 to recommend that the TIDE study continue if Avandia stays on the market. The study had originally been mandated by the FDA.

The two advisory committees voted 20-to-12 at the meeting to recommend that the federal agency allow Avandia to stay on the market in spite of concerns about the risk of heart attack and stroke. Most of the advisors who favoured allowing continued marketing of the drug also pushed for new warnings and restrictions.

22nd July 2010

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