Though the data from two large, ongoing trials involving ezetimibe/simvastatin (Vytorin) show no increased risk of cancer, the FDA is reviewing a recent study, called SEAS (Simvastatin and Ezeimibe in Aortic Stenosis), which found an increased risk of cancer and deaths from cancer in patients taking the drug.
The FDA said the review will take about three months and likely take the agency six months to fully evaluate the data. Detailed results of the Seas study will be presented at a cardiology conference in Munich on Sept. 2.
Until that time, the FDA said physicians should continue to monitor patients taking the combination and report side effects to the agency. The reviews should not prompt patients to stop taking Vytorin or any other cholesterol-lowering drug, the agency added.
Vytorin is made by a joint venture of Merck & Co. and Schering-Plough Corp.
