FDA to Explore Possible Vytorin-Cancer Link
Experts, FDA Advise Patients to Talk to Their Doctors
By Daniel J. DeNoon
WebMD Health News
Reviewed By
Michael W. Smith, MD
Aug. 21, 2008 — The FDA is reviewing the safety of Vytorin, which combines the cholesterol-lowering drugs Zocor and Zetia, after a clinical trial linked the drug
to cancer risk.
In the trial, called SEAS, 4.1% of patients taking Vytorin died of some form
of cancer — more than the 2.5% of patients who received an inactive
placebo.
A recent statement issued by the study investigators noted that these
differences "are small and could have occurred as a result of
chance."
While other clinical trial data do not indicate an increase in cancer risk,
the FDA is alerting doctors and patients now while it awaits further data from
the manufacturers, which they should receive in about three months. After that
point, the FDA says it'll take an additional six months for a complete
evaluation of the data.
Based on all available data on the link between Vytorin and cancer risk, the
FDA says patients should not stop taking Vytorin or any other cholesterol
drug.
The American Heart Association says the same thing, recommending that
patients taking prescribed cholesterol-lowering drugs should not stop taking
them without talking with their doctor. Patients who stop taking prescribed
cholesterol medications increase their risk of having a heart
attack or other cardiovascular event.
Vytorin is jointly marketed by Merck and Schering-Plough. Schering-Plough
tells WebMD it is cooperating with the FDA.
"We believe that the findings in SEAS on cancer are likely to be an
anomaly," Schering-Plough's Mary-Fran Faraji tells WebMD. "We don't
believe, in light of all the data, that there's an association [of cancer] with
Vytorin."
A recent study reviewing cancer risk from Zocor and other
cholesterol-lowering statin drugs found no link between statin use and cancer,
contradicting its own preliminary findings that did suggest such a link.
"When you put all of the information together, there is no evidence that
statins increase the risk of cancer," researcher Richard Karas, MD, says in
a news release in response to those study findings.
In addition, interim data from two ongoing trials of Vytorin show no
increased risk of cancer in patients receiving the drug. The first of these
trials (the SHARP study) won't be finished until 2010; the second (the
IMPROVE-IT study) will end in 2012.
In a separate development, the U.S. House Energy and Commerce Committee is
investigating the SEAS study and today asked Merck and Schering-Plough for
details.
Faraji says both companies are cooperating with that investigation.
Earlier this year, Vytorin suffered another setback when a clinical trial
showed that Vytorin did not reduce artery-clogging plaque better than Zocor alone.
WebMD's Miranda Hitti contributed to this report.
SOURCES: FDA web site: "Early Communication About an
Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin),
Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia): FDA
Investigates a Report from the SEAS Trial." Merck. News release, Terje R. Pedersen, July 21, 2008. News release, American Heart Association, July 21, 2008. Faraji, M-F. Email communication, Aug. 21, 2008. Alsheikh-Ali, A.A. Journal of the American College of Cardiology,
published online ahead of print, Aug. 20, 2008. News release, Tufts Medical Center.
©2008 WebMD, LLC. All Rights Reserved.
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