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Title: FDA Analysis Shows Statins Do Not Increase the Risk of ALS
URL: http://www.pslgroup.com/dg/22DD42.htm
Doctor's Guide
September 29, 2008

ROCKVILLE, Md -- September 29, 2008 -- A US Food and Drug Administration's (FDA) analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS). The analysis was reported in the September 29 issue of Pharmacoepidemiology and Drug Safety.

"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," said Mark Avigan, MD, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA, Rockville, Maryland.

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.

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 FDA's paper, "An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in the FDA's spontaneous adverse event reporting system," documents that during the course of long-term placebo-controlled clinical trials, 9 of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS.

From this 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. Avigan.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is currently being conducted. Results from this study should be available within 6 to 9 months.


SOURCE: US Food and Drug Administration

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