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FDA Investigates Potential Link Between Vytorin and Cancer
The FDA is examining preliminary data from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study showing that Vytorin (simvastatin plus ezetimibe) may be associated with increased risks for cancer and cancer death.
The agency does not currently recommend that patients discontinue Vytorin or other cholesterol-lowering drugs. Rather, it cites various studies, including two large ongoing trials of Vytorin, that have not shown an association between statin use and cancer risk.
The FDA is awaiting final data from the SEAS study and will publish its conclusions and any recommendations once the review is complete — about 9 months from now, the agency says.
LINK(S):
FDA early communication (Free)
Associated Press story (Free)
Physician's First Watch coverage of SEAS results (Free)
Published in Physician's First Watch August 22, 2008
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