Increased risk of muscle injury with high doses of Zocor (simvastatin).

Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.

Audience: Primary care providers, patients
[Posted 03/19/2010] FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.
Recommendations for healthcare professionals, recommendations for patients and a data summary of information used in this ongoing review are provided in the Drug Safety Communication.
[03/19/2010 - Drug Safety Communication¹ - FDA]
[03/2010 - Prescribing Information: Zocor² - Merck]

Early Communication about an Ongoing Review of Vytorin By FDA

FOR IMMEDIATE RELEASE January 25, 2008

Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Issues Early Communication about an Ongoing Review of Vytorin

The U.S. Food and Drug Administration today issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study – the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) – on this cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.

The FDA is informing the public that the agency will conduct a review of Merck and Schering Plough’s recent trial once the FDA receives the final study results.

Merck/Schering Plough Pharmaceuticals issued a press release reporting preliminary results of the study and stated that the study demonstrated no significant differences between the combination product and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries. The study was not designed to detect any difference in risk of having a heart attack or stroke between the two treatments. An ongoing trial called -- Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT) -- is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke.

This Early Communication is in keeping with the FDA's commitment to inform the public about its ongoing review of drugs. Until the FDA reviews the data, the agency advises patients to talk with their health care providers if they have questions about the ENHANCE study.

Full text of the Early Communication about an Ongoing Data Review for the ENHANCE Study can be found at: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm.

tag: FDA, Vytorin, Ezetimibe, Simvastatin, Simvastatin, Atherosclerotic, Heterozygous Familial Hypercholesterolemia, Zetia, ezetimibe, Zocor, Merck and Schering Plough, ENHANCE study