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