FDA investigates Vytorin cancer risk

The FDA is investigating a possible increased incidence of cancer in patients taking Vytorin (ezetimibe/simvastatin, from Merck/Schering-Plough). An observation from the 5-year SEAS trial showed that a larger percentage of subjects taking Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo. After a review of the final SEAS report, the FDA will communicate its conclusions and recommendations regarding a possible Vytorin and cancer link. Until such time, the FDA is advising patients to continue taking Vytorin and other cholesterol lowering drugs.

Vytorin, is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, TG, and non–HDL-C; to increase HDL-C in primary hypercholesterolemia or mixed hyperlipidemia; and to reduce elevated total-C and LDL-C in homozygous familial hypercholesterolemia.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm085992.htm.