FDA Report Stresses Avandia Heart Risks

People with diabetes have a higher risk of heart attack and death if they use the drug rosiglitazone (Avandia), a research review finds. Scientists from the U.S. Food and Drug Administration (FDA) did the review of prior research. It was released July 9. This week, the FDA is assembling a group of outside experts to look at the evidence about Avandia. FDA scientists don’t all agree on how much risk the drug presents, an official told the Associated Press. One FDA scientist involved in the report criticized a major study often cited as supporting Avandia’s safety. He said the study has serious flaws. The experts will vote this week on whether to recommend more restrictions for Avandia. The FDA could require stronger warning labels, limit who can get the drug, or remove it from the market. The FDA does not have to follow the advice of outside experts, but it often does.