Rosiglitazone Restrictions Lifted by FDA

Written by Kristin Della Volpe

Commentary by Jennifer Frost, MD

The U.S. Food and Drug Administration (FDA) announced that it has eliminated the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines (ie, Avandia, Avandamet, Avandaryl, and generics), according to a statement from the FDA.

In 2013, the FDA removed prescribing and dispensing restrictions for rosiglitazone-containing medicines instituted in 2010 after determining that recent data did not demonstrate an increased risk of heart attack and other adverse cardiovascular events with these agents compared to metformin and sulfonylurea. Previous data from a large, meta-analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, which prompted the FDA to institute the rosiglitazone REMS program restricting the use of rosiglitazone medicines.

Continuous monitoring of rosiglitazone-containing medicines identified no new pertinent safety information, resulting in the FDA’s determination that the REMS is no longer necessary.

“Good News” For Prescribers, Expert Says
“The use of rosiglitazone-containing medications has decreased significantly due to concerns about cardiovascular safety,” commented Jennifer Frost, MD, Medical Director of the American Academy of Family Physicians' Health of the Public and Science Division. “The FDA has determined that the evidence does not support these concerns, and therefore, a REMS is no longer necessary.”

“This is good news for prescribers as well as patients struggling to manage their diabetes,” Dr. Frost said. “Being able to prescribe these medicines without having to worry about cardiovascular risk gives family physicians and patients another option for blood sugar control. There are several diabetes medications available, but not all work well or are tolerated by every patient. Patients may have to try several medications and combinations to find what works best for them, and now there is another choice.”

December 18, 2015

Sources

U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines. http://www.fda.gov/Drugs/DrugSafety/ucm476466.htm. Accessed December 16, 2015.

U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines. http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm. Accessed December 16, 2015.

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