FDA Drug Safety Communication: Ongoing Safety Review of High-dose Zocor

m Bookmark and Share
03/30/10
The American Nurses Association (ANA) received the following safety announcement from the U.S. Food and Drug Administration (FDA):

Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about 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.

The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency 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.

Read full FDA Safety Announcement.

From: 
Email:  
To: 
Email:  
Subject: 
Message: