FDA: statins do not increase the risk of amyotrophic lateral sclerosis (ALS)

From FDA’s patient safety news website:

Statin Use and the Risk of ALS

A recent FDA analysis provides new evidence that using statins does not increase the risk of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease also known “Lou Gehrig’s Disease.” Cholesterol-lowering statins such as Lipitor (atorvastatin calcium) and Zocor (simvastatin) have been shown to reduce the risk of heart disease in a wide variety of patients.

FDA undertook its review after receiving a higher than expected number of reports of ALS in its adverse event reporting system. FDA’s report, which was published recently in the journal Pharmacoepidemiology and Drug Safety, was a pooled analysis of 41 clinical trials ranging from 6 months to 5 years duration. In this analysis, the incidence of ALS was 4.2 cases per 100,000 patient-years in trial patients treated with statins, and 5.0 cases per 100,000 patient-years in patients receiving placebo. These results showed that patients treated with a statin did not have an increased incidence of ALS compared with placebo patients. FDA will continue to evaluate additional data as it becomes available.

Additional Information:

FDA MedWatch Safety Alert. Statin drugs and amyotrophic lateral sclerosis (ALS). September 30, 2008.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin

Statins mechanism of action

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