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FDA Lifts Restrictions on Rosiglitazone

Aschenbrenner, Diane S. MS, RN

AJN The American Journal of Nursing: April 2014 - Volume 114 - Issue 4 - p 24
doi: 10.1097/01.NAJ.0000445681.44930.17
Drug Watch

Diane S. Aschenbrenner recently retired as course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch :

The Food and Drug Administration (FDA) has decided to lift many of the restrictions it had placed on the antidiabetic drug rosiglitazone (Avandia) in 2011. Those restrictions were based primarily on findings from a meta-analysis of clinical trials and observational studies that suggested that the drug increased the risk of cardiovascular events such as myocardial infarction. The decision to impose restrictions was also related to findings from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, which originally suggested that rosiglitazone increased the risk of heart attack but decreased the risks of stroke and death. The FDA requested that the data from the RECORD trial be reevaluated by independent experts, and the findings from that reevaluation became the basis for the FDA's change regarding the need for tight restrictions on rosiglitazone use. The reevaluation showed that rosiglitazone actually produced fewer deaths from cardiovascular causes, stroke, and heart attack; fewer nonfatal strokes; and fewer deaths from all causes than treatment with metformin or sulfonylurea, although the differences weren't statistically significant. The original trial didn't compare rosiglitazone with a placebo, so the possibility of increased cardiovascular risk couldn't be ruled out in the data reexamination.

The new findings were discussed June 5 and 6, 2013, at the FDA's joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committee members voted to remove many of the restrictions on use of the drug: there will no longer be tight restrictions on which patients can be prescribed rosiglitazone; the drug can be freely prescribed to treat any patient with type 2 diabetes whom the prescriber believes would benefit from the drug; health care professionals, pharmacies, and patients will also no longer be required to enroll in the rosiglitazone Risk Evaluation and Mitigation Strategy program, which monitored prescription and dispensation of rosiglitazone and combination drugs containing rosiglitazone. Prescribers will still be required to receive training that highlights the current state of knowledge regarding cardiovascular risks associated with rosiglitazone.

This decision is considered controversial by some practitioners because rosiglitazone hasn't been available for sale in Europe for several years because of safety concerns. And patients may not understand why a drug that was previously considered dangerous no longer requires tight restrictions. Nurses need to be familiar with these changes. They should be able to explain the current status of the drug and how, as knowledge advances, recommendations on use of a drug can change. Nurses should also encourage patients to read the medication guide that accompanies every rosiglitazone prescription to have the most current information on adverse effects.

The FDA Drug Safety Communication regarding the new regulations can be found at

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