The US Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs do not show an increased risk of myocardial infarction (MI) compared with the standard type 2 diabetes medicines metformin and sulfonylurea.

As a result, the FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. The decision is based on the FDA’s review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI), Durham, North Carolina.

Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, the FDA’s concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. The FDA is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.