[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

Zocor (simvastatin): increased risk of muscle injury with high doses-risk also increased when drug, especially at higher doses, is used with certain drugs



Title: Zocor (simvastatin): increased risk of muscle injury with high doses-risk also increased when drug, especially at higher doses, is used with certain drugs
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Zocor (simvastatin): increased risk of muscle injury with high doses

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

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.

Read the complete MedWatch 2010 Safety summary, including a link to the Safety Communication and current Prescribing Information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205404.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

FDA HHS

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420


[CDC News]     [NIH News]     [USDA News]     [Photo]     [Yosemite in Winter]     [Hot Springs Photos]     [Steve's Art]     [Camping in Yosemite]     [Yosemite Photos]     [PhotoForum]     [SB Lupus]     [STB]

Add to Google Powered by Linux