Avandia liver reports won't affect labeling

Medical Marketing and Media, Mar 2000

The FDA has decided not to pursue any labeling change or additional warnings for SmithKline Beecham's diabetes treatment Avandia (rosiglitazone), despite reports of liver injury associated with the drug. In response to two cases of Avandia-associated liver injury reported in the 1/18 Annals of Internal Medicine, CDER Office of Drug Evaluation II Director John Jenkins told the Washington Post that no changes are being considered based on data the FDA has received.

He acknowledged that other reports of Avandia-associated liver toxicity have been received at the FDA, but none of these cases have been confirmed.