FDA announces new safety recommendations for high-dose simvastatin

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA announces new safety recommendations for high-dose simvastatin

You are subscribed to FDA Press Releases for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

FDA announces new safety recommendations for high-dose simvastatin

06/08/2011 02:24 PM EDT

The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.

.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? support@xxxxxxxxxxxxxxx
• Other inquiries? webmail@xxxxxxxxxx

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420