Investigation Raises More Questions About Avandia

Sept. 6, 2010— -- On July 15 -- a day after the U.S. Food and Drug Administration completed two days of hearings on the diabetes drug Avandia -- a British advisory commission on drugs concluded that the product should be withdrawn from the market, according to an investigation conducted by BMJ.

The Commission on Human Medicines' opinion was passed on to the U.K.'s regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), which has now told BMJ that Avandia "no longer has a place on the U.K. market." The evidence for increased risk of heart attacks outweighs any potential benefit, according to an MHRA statement given to BMJ.

Yet six weeks after the commission submitted its recommendations on rosiglitazone, the drug is still on the market in Britain. The MHRA has yet to share its negative assessment of the drug with either physicians or patients.

Read this story on www.medpagetoday.com.

Instead, on July 26 it sent providers a "dear doctor" letter suggesting merely that it would be wise to consider alternatives to Avandia, wrote Deborah Cohen, features editor at BMJ.

The BMJ investigation was detailed in a feature article published online today and also the subject of a BBC news report. The report appears to be the first confirmation that U.K. regulators are ready to withdraw the drug from the market.

The lengthy article reveals no new information about the FDA's handling of Avandia from its approval through two subsequent safety reviews, but it does give insight into the machinations of the approval process in Europe.

For example, the European Medicines Agency initially rejected Avandia, only to come back a year later in 2000 to approve the drug. As a condition of that approval, the EMA ordered a post-marketing study to verify the safety of the drug. That study, called RECORD, was an open-label trial that has been roundly criticized on both sides of the Atlantic for its poor design.