FDA panel divided on rosiglitazone

A panel that advises the FDA was divided last week in a vote on whether rosiglitazone (Avandia) should be removed from the market.

The panel has 33 members, 12 of whom voted that rosiglitazone should be withdrawn. Ten members voted that sale of the drug should be restricted and its warnings strengthened, while seven favored only strengthening the warnings and three voted for no changes, according the July 14 New York Times.

After reviewing large amounts of data, the advisory panel also found that there was sufficient evidence to be concerned that rosiglitazone increases the risk of heart attacks and strokes but insufficient evidence that it increases the risk of death, reported the July 15 Washington Post. The panel also recommended that the FDA approve a large head-to-head trial against pioglitazone (Actos).