Statins do not increase the risk of amyotrophic lateral sclerosis (ALS), according to a meta-analysis by the FDA.
Prompted by a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins from inside and outside the US, the FDA asked statin manufacturers to provide information on how many cases of ALS were diagnosed during all of their placebo-controlled statin trials that lasted 6 months or more.
From a total of 41 trials totalling around 200,000 patient-years of exposure to a statin and about the same to a placebo, 9 cases of ALS were reported in statin-treated patients and 10 cases in those treated with placebo.
"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis (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," the investigators noted.
Reference
Colman E, Szarfman A. et al. 2008, ‘An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system’ Pharmacoepidemiol DrugSaf 2008; DOI: 10.1002/pds.1643.
Abstract