ARTICLE | Clinical News

Avandia rosiglitazone regulatory update

January 4, 2016 8:00 AM UTC

FDA removed the REMS for rosiglitazone-containing Type II diabetes drugs. The move comes 5 years after FDA issued the REMS warning of potential increased cardiovascular risk and 8 years after a meta-analysis first implicated GlaxoSmithKline’s Avandia in causing increased cardiovascular events. FDA issued a drug safety update that said the agency identified no new safety issues in rosiglitazone-containing drugs. “The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks,” the update said.

Red flags around the safety of Avandia were raised in 2007 when a meta-analysis from researchers at the Cleveland Clinic found a 43% higher risk of myocardial infarction and a 64% increase in the risk of CV mortality for Avandia. FDA added the REMS in 2010 to include patient and prescriber certification programs as well as a restricted distribution system. However, a subsequent analysis and re-analysis of the CV outcomes trial RECORD showed no increased risk of CV mortality for Avandia. ...