FDA Removes REMS for Rosiglitazone

The U.S. Food and Drug Administration (FDA) is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone, stating that it is no longer necessary to ensure that the drug’s benefits outweigh its risks, according to an updated drug safety communication from the agency.

The FDA’s decision extends to all approved rosiglitazone-containing medicines for type 2 diabetes, including Avandia (GlaxoSmithKline), Avandamet (rosiglitazone/metformin, GlaxoSmithKline), Avandaryl (rosiglitazone/glimepiride, GlaxoSmithKline), and generics.

After a meta-analysis, published in the New England Journal of Medicine in 2007, linked rosiglitazone use with increased risks for myocardial infarction and cardiovascular death, the FDA required a black box warning for the drug. Then, in 2010, the agency further restricted its use as part of a REMS. In 2013, however, the agency modified the REMS and lifted some of its restrictions following discussion of an independent, FDA-requested readjudication of data from the RECORD trial (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes).

“In 2013, we required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea,” the agency stated in its updated safety communication.

“We also required the drug manufacturers to provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have since fulfilled these requirements.”

The FDA noted that it has identified no new pertinent safety information during its continued monitoring of rosiglitazone-containing medicines, which has contributed to its decision that the REMS is no longer necessary.

References

1. FDA Drug Safety Communication: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/ucm476466.htm. December 16, 2015. Accessed December 16, 2015.
2. Nissen SE, Wolski K. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med. 2007;356:2457-2471.