WASHINGTON – Avandia, a diabetes drug that could increase the risk of heart attacks in some patients, got a tougher warning label Wednesday, but the government decided against the more drastic step of halting sales.
The Food and Drug Administration advised patients with Type 2 diabetes who take Avandia to consult their doctors if they suffer from heart disease or are at high risk of a heart attack, and it urged physicians to closely monitor patients. But the agency rejected calls to withdraw the oral drug from the market, saying its potential heart attack risks required further study.
Seven million patients have taken Avandia since it was approved in 1999, but use of the drug has plunged since a prominent cardiologist reported in May that the prescription medicine raised the risk of heart attacks.
The report, in the New England Journal of Medicine, sparked requests for a halt to sales of the drug.
The FDA also asked GlaxoSmithKline, maker of Avandia, to study potential heart-related risks.