Safety Review: Vytorin and Increased Risk of All-Types Cancer
An early communication was released from the U.S. Food and Drug (FDA) administration regarding a study of the safety of Vytorin ( a combination of simvastin and ezetimibe). Vytorin is used to decrease LDL cholesterol – each by a different mechanism and affecting different pathways of cholesterol absorption and metabolism. FDA is currently investigating the report from the SEAS trial (Simvastin and Ezetimibe in Aortic Stenosis) to see if there is a possible association between the use of Vytorin and increased incidences of cancer.
Recently FDA received preliminary results from the trial. A lowered overall cardiovascular risk reduction was not found with the use of Vytorin as stated by the manufacturers. What was found was a higher rate of cancer diagnoses and death from cancer in the treatment group for those on Vytorin when compared to the placebo study, which lasted five years.
Interim data from two other trials do not show such an association. The Study of Heart and Renal Protection (SHARP) and the Improved Reduction in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMPROVE-IT) study showed no association between Vytorin and cancer.
The application of this data is that individuals should maintain their Vytorin intake as prescribed until further data is in and all the data can be evaluated. Population based recommendations will be forthcoming within the following year from FDA.
In the meantime, individuals who experience an adverse reaction to Vytorin should report it to the FDA’s Med-Watch program.
Report by:
Calling 1-800-332-1088
Online: www.fda.gov/medwatch/report.htm
About the author
Kathy Shattler received her Master of Science degree from Michigan State University in E. Lansing Michigan in Human Nutrition. Her twenty-two years of practice includes holding positions as a Lecturer, Chief Clinical Dietitian and Program Manager. Kathy is the Founder of Nutri-Care Consulting and is currently the Nutrition Director of www.CEU4U.COM, an online continuing education management company for Registered Dietitians and Dietetic Technicians.
