News | September 30, 2008

FDA Says Statin Drugs do Not Raise ALS Risk

October 1, 2008 – A new FDA analysis released yesterday provides new evidence 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 analysis, undertaken after the agency received a higher than expected number of 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.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within the next six to nine months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, healthcare professionals should not change their prescribing practices for statins and patients should not change their use of statins, the FDA said.

For more information: www.fda.gov

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