Statins Don't Raise Risk of Amyotrophic Lateral Sclerosis
But FDA will continue to study the issue
TUESDAY, Sept. 30 (HealthDay News) -- Using statins does not raise the risk of developing amyotrophic lateral sclerosis (ALS), according to research conducted by the U.S. Food and Drug Administration and published online Sept. 29 in Pharmacoepidemiology and Drug Safety.
Eric Colman, M.D., of the FDA in Silver Spring, Md., and colleagues conducted a meta-analysis of data from 41 statin clinical trials comprising approximately 64,000 patients treated with statins and approximately 56,000 subjects who received placebo. The study was undertaken in response to a higher than expected number of reports to the FDA's adverse event reporting system of patients on statins who developed ALS.
There were nine cases of ALS reported among the treatment subjects and 10 cases among the placebo-group subjects, the investigators found.
"While the FDA finds the lack of an increase in the incidence of ALS in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted," Mark Avigan, M.D., of FDA's Center for Drug Evaluation and Research, said in a statement. "The FDA's review, which began in 2007, is an example of the agency working to analyze products -- throughout their lifecycle -- to keep health care professionals and patients informed of new and emerging safety data."