FDA Panel Votes to Keep Avandia on Market, With Tighter Restrictions

A federal advisory panel voted to allow continued sales of Avandia, with added restrictions on marketing of the controversial diabetes drug, which has been linked to increased risks of heart attack and stroke.

Of the 33 members of the Food and Drug Administration panel, 12 voted to withdraw the drug made by GlaxoSmithKline, while most of the others favored leaving it on the market with stiffer label warnings or restrictions on its sale.

Some doctors and diabetes patients asked the FDA to permit continued sales of Avandia because of its effectiveness and ability to prevent complications related to the disease, like blindness, The Washington Post reports:

“In making this plea to keep Avandia on the market, I believe I am pleading for my life,”  said Chuck Keyserling, who has been taking Avandia for 10 years. Keyserling said alternative drugs, such as Actos, have not worked for him and other patients. “For those patients, a negative decision about Avandia may be a death sentence.”

The panel did say, however, that Avandia appears to have more risks than Actos.

A 2007 study published in The New England Journal of Medicine first raised questions about the drug’s safety when it said Avandia raised the risk of heart attacks by more than 40 percent. A Glaxo-funded study released last year did not show an increased risk.

Recently, Glaxo has come under fire for failing to report the results of a 1999 study that suggested Avandia caused heart problems. Yesterday, the company agreed to a $460 million settlement with about 10,000 plaintiffs who claim that the company hid evidence of the drug’s side effects.

Margaret A. Hamburg, FDA commissioner, will have the final say about the drug. In the past Hamburg has pledged to make drug safety a priority, the Post reports.

Print Print  

Like what we're doing? We'd appreciate your support.

Leave a comment