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Posted: October 07, 2008

FDA: Statins Cleared for Now in Suspected Link to Lou Gehrig's Disease

A Food and Drug Administration analysis 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 was undertaken after the federal agency received a higher than expected number of reports of ALS occurring in patients on statins. Results of the analysis, which was based on data from 41 long-term controlled clinical trials, showed no increased incidence of the disease in patients treated with a statin compared with placebo. 

Statins – technically known as HMG-CoA-reductase inhibitors -- are the most commonly prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age. 

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"Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins," the agency said. 

During the course of the FDA's long-term placebo-controlled clinical trials, nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. 

From these data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years. 

"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis 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," said Dr. Mark Avigan, a director at the FDA’s Center for Drug Evaluation and Research. 

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Dr. Lorene Nelson, chief of the Division of Epidemiology at the Stanford University School of Medicine, and colleagues in the Division of Research at Kaiser Permanente. Results from this study should be available within six to nine months. 

FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins. 

(Article courtesy of

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