The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the risk of cardiovascular (or unknown cause) death, myocardial infarction, or stroke.2

1. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines. Available at www.fda.gov. Accessed January 27, 2014.

2. KW Mahaffey et al. Results of a reevaluation of cardiovascular outcomes in the RECORD trial. Am Heart J 2013; 166:240.