US FDA: No new conclusions on Glaxo’s Avandia yet Date posted: Mon Feb 22 16:17:45 EST 2010 (Reuters Health)

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Monday it is reviewing data on possible heart risks with GlaxoSmithKline Plc’s controversial diabetes drug, Avandia, but has not reached any conclusions yet.

The agency will hold a public meeting in July 2010 to discuss risks and benefits of the drug, but in the meantime doctors and patients should continue to use Avandia as directed, the agency said in a statement.

"This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone (Avandia) in the treatment of type 2 diabetes have been made at this time," the FDA said, referring to the drug’s generic name.

On Saturday, two U.S. senators released a report on Avandia and internal FDA documents. The documents included a 2008 memo from two FDA drug safety reviewers who recommended pulling Avandia from the U.S. market because they concluded it was more dangerous to the heart than rival drug Actos by Takeda Pharmaceutical Co Ltd.

The agency said on Monday it is reviewing data from a Glaxo-sponsored study known as Record, as well as an observational studies that look at the cardiovascular safety of Avandia. The FDA will present all of the safety data at a public advisory panel meeting in July.

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