The U.S. Food and Drug Administration (FDA) has completed its review of a possible link between Zetia^® (ezetimibe) and an increased risk of cancer or cancer-related death. According to the FDA review, Zetia^® is likely to be safe.

The FDA’s review of both Zetia^® alone and the combination of Zetia^® and simvastatin was based on findings from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, a study that showed that significantly more patients treated with simvastatin developed and died from cancer of all types than patients taking placebo over a five-year period. According to the FDA, based on currently available evidence, it is unlikely that Zetia^® or simvastatin increase the risk of cancer or cancer-related death.

The FDA also reviewed data from two ongoing studies with Zetia^® -- the Study of Heart and Renal Protection (SHARP) and the Improved Reduction in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMPROVE-IT) trials. They failed to find a consistent pattern of increased cancer risk among those patients treated with Zetia^® and/or simvastatin.

At this point, the FDA is not advising that healthcare professionals or consumers to stop using Zetia^® or simvastatin. Instead, the FDA is recommending that healthcare professionals continue to evaluate the clinical benefits and potential risks of Zetia^® and simvastatin in comparison with other FDA-approved medications for lowering cholesterol.

Source:

U.S. Food and Drug Administration website.