U.S. restrictions, EU suspension for Avandia

FDA and the European Medicines Agency issued simultaneous decisions on Thursday based on cardiovascular safety concerns that would significantly restrict use of Avandia rosiglitazone in the U.S. and suspend the diabetes drug in the EU. FDA said Avandia will only be available to new patients who achieve inadequate glycemic control on other medications and are unable for medical reasons to take Actos pioglitazone, the only other drug in the thiazolidinedione (TZD) peroxisome proliferation activated receptor (PPAR) agonist class. Patients already receiving Avandia will have the option to continue. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), which markets Avandia, will develop a REMS to restrict access.

FDA ordered GSK to commission an independent review of the Phase IIIb RECORD trial of Avandia. The agency noted potential bias in the trial's conduct and said it may take additional actions based on the review. Additionally, FDA halted the TIDE postmarketing study, which was already subject to a partial clinical hold. In July, an FDA panel was divided between members recommending taking steps to reduce the risks associated with the drug and those backing withdrawal. ...