Ongoing Review of Cholesterol Drug Vytorin
FDA issued an Early Communication on January 25, 2008, announcing that it will conduct a review of Merck/Schering Plough's recently completed study on Vytorin (ezetimibe/simvastatin) once the agency receives the final results. This Early Communication is based on information that FDA has not yet fully evaluated.
Merck/Schering Plough Pharmaceuticals issued a press release on January 14, 2008, reporting that there was no significant difference found between Vytorin and simvastatin alone in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries, despite greater lowering of bad cholesterol (LDL).
FDA has not received a final study report and at this time, it is not clear why the lower levels of LDL cholesterol in patients who took Vytorin did not lead to lesser amounts of plaque, compared to patients treated with simvastatin alone.
Until FDA reviews the study data, patients are advised to talk with their health care providers if they have questions about the study or the cholesterol-lowering drug. FDA's Early Communication reinforces its commitment to inform the public about its ongoing drug reviews.
FDA will provide updates as new information becomes available.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: January 30, 2008