Pull diabetes drug Avandia off market, FDA reports say

Written by Andrew Traub

February 22, 2010

Hundreds of people taking the diabetes drug Avandia needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend that the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.

Avandia, intended to treat type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one of the reports, written by Drs. David Graham and Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal FDA reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline.

Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients.

The battle has been brewing for years but has been brought to a head by a fierce disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the FDA to issue a warning, and sales plunged.

The bipartisan, multiyear Senate investigation — whose results are expected to be released publicly today but which werealso obtained by the Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

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