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.