FDA panel votes to keep Avandia on U.S. market; data remain confusing

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After two days of toiling over whether GlaxoSmithKline’s diabetes drug rosiglitazone (Avandia) should remain on the shelves, 12 members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted that the drug be pulled from the shelves, while the other 20 members recommended that it be continued on the market.

Of the 20 committee members who voted in the affirmative, three voted for the drug to stay on the U.S. market with no added changes, seven voted for continued marketing with revisions to the current drug labeling and 10 voted to add further restrictions and warning labels.

In his response, Peter J. Savage, MD, of the National Institute of Diabetes, Digestive and Kidney Diseases and National Institutes of Health in Bethesda, Md., said that the present evidence of the potential harms associated with rosiglitazone was “substantially greater” than what was presented during the 2007 debate. And, while he voted that the drug remain on the market with the addition of further warnings, he said that a black box warning may not be entirely “sufficient” in protecting patients.

Additionally, the committee found that data presented over the last day and a half were significant to warrant change and raise concerns with the drug, while others contended that data may be insufficient, dissuading some members from making a decision. Eighteen members voted that data presented warranted concern; six voted that these data were not sufficient—nine members voted that they were unable to make a finding based on data.

“I thought they [studies] were inconclusive,” said Arthur J. Moss, MD, professor of medicine and cardiology at the University of Rochester School of Medicine & Dentistry in Rochester, N.Y., speaking at the studies and data presented. “I couldn’t come to any clear-cut conclusion," he said.