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

[Ross]

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/...tyAlertsforHumanMedicalProducts/ucm205404.htm

 

[hensylee]

any statin can cause muscle damage. even the health food store kind can do it. As some of us here in VR can attest. I know they are valuable to reduce cholesterol, but I'd rather walk. Can't even do it much anymore.

 

[nngbwh]

I know my mom was taking simvastatin 80mg develop muscle pain. Took her to the hospital and found out her cpk blood level was over 22,000.
Normal cpk level should be 400 - 500.

 

[karen14]

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/...tyAlertsforHumanMedicalProducts/ucm205404.htm

Interesting Ross! Thank you. I was just upped my dose of Simvastatin to 80mg, lol, ironic. ~Karen