An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), the neurodegenerative disorder commonly called “Lou Gehrig’s disease.”
The analysis, reported in Pharmacoepidemiology and Drug Safety (2008; published online ahead of print), was undertaken after the agency’d Adverse Event Reporting System was notified of ALS in patients taking statins.
The results of the review, based on data from 41 long-term controlled clinical trials, showed no greater occurrence of the disease in patients treated with a statin compared with placebo.
ALS is a fatal condition with a yearly overall incidence of one to two cases per 100,000 population.
FDA recommends no change in prescribing and use of statins at this time, but “given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted,” said Mark Avigan, MD, director of the agency’s Division of Pharmacovigilance I, Center for Drug Evaluation and Research.