FDA panel finds middle ground on Rezulin

BETHESDA, Md. - An FDA advisory panel attempted Friday to split the difference between an alarming presentation by the agency asserting that Rezulin troglitazone causes a high rate of potentially fatal liver disease, and data from clinicians and Parke-Davis suggesting that the adverse reactions are rare and can be further reduced with proper treatment. FDA convened the unusual meeting to discuss safety concerns that have been raised since the drug was approved to treat insulin resistance in Type II diabetes.

In an 8 to 4 vote, the Endocrinologic and Metabolic Drugs Advisory Committee said that Rezulin should not be used as a monotherapy, an indication that is currently included on the product's label...