FDA removes Avandia REMS

FDA removed a REMS for diabetes drug Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The move comes five years after FDA issued the REMS warning of potential increased cardiovascular risk, and eight years after a meta-analysis first implicated the drug in causing increased cardiovascular events.

On Tuesday, 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. ...