The FDA Monday published new evidence suggesting that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, often referred to as Lou Gehrig's Disease.
“The FDA’s review, which began in 2007, is an example of the agency working to analyze products— throughout their lifecycle—to keep healthcare professionals and patients informed of new and emerging safety data,” said Mark Avigan, MD, director of the division of pharmacovigilance I at the FDA’s Center for Drug Evaluation and Research.
The FDA analysis, undertaken after the agency received a higher than expected number of adverse event reporting system reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.
According to agency, statins are the most commonly-prescribed medications to treat elevated cholesterol levels in the U.S. ALS is a fatal neurodegenerative condition with an overall annual incidence of one to two per 100,000 people in the general population. The incidence of ALS increases with age.
The analysis was published Monday in Pharmacoepidemiology and Drug Safety.