FDA Warns of Possible Vytorin Cancer Link

Scott Kappes

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The U.S. Food and Drug Administration has issued an “Early Communication” about a possible link between the blockbuster cholesterol medication Vytorin and an increased risk of cancer. The communication comes as the FDA is investigating a report from the SEAS trail (Simvastatin and Ezetimibe in Aortic Stenosis) of a possible link between the use of Vytorin and an increased incidence or cancer.

Vytorin is a combination of the medications simvastatin (Zocor), used to decrease the production of cholesterol and prevent cardiovascular events, and ezetimibe (Zetia) which blocks the absorption of cholesterol to reduce LDL-cholesterol levels.

Recently, FDA obtained preliminary results from the SEAS trial. This clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of major cardiovascular events, including aortic valve replacement, congestive heart failure, and ischemic cardiovascular events in individuals with aortic stenosis (a tight heart valve). A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined (including skin cancer) when compared to placebo during the 5-year study.

Two other ongoing cardiovascular studies on Vytorin, the SHARP and IMPROVE-IT studies, have not shown evidence of this link to date but are being closely monitored for any possible signs of a link.

The FDA expects to have the final report on the SEAS study in about three months and will likely take the agency another six months to fully evaluate the findings of the study. The FDA will communicate any further recommendations and conclusions to the public when the data becomes available.

In the interim the FDA urges both healthcare providers and patients to report any side effects or adverse events associated with Vytorin use to the agency’s MedWatch Adverse Event Reporting Program.