FDA Analysis Determines No Link Between Statins and ALS
By: Drucilla Dyess
Published: Tuesday, 30 September 2008


On the heels of the Veteran Administration announcing service-related benefits for veterans with amyotrophic lateral sclerosis (ALS), the U.S. Food and Drug Administration (FDA) has issued a release for the general population that statins do not increase the risk of ALS. Statins are a class of medications prescribed to help lower cholesterol and are one of the most effective classes of drugs in reducing elevated LDL (bad) cholesterol.

After performing an analysis on 41 long-term controlled clinical trials, U.S. health officials have reported findings that the widely used statin cholesterol drugs do not increase the risk of ALS. The FDA began the analysis after receiving a higher than expected number of reports of the condition, commonly known as Lou Gehrig's disease, in patients being treated with cholesterol-lowering statin drugs.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Among this class of drugs used by millions are Lipitor, from the maker Pfizer, Crestor, made by AstraZeneca, Merck & Company’s Zocor, and Bristol-Myers Squibb Company’s Pravachol. These drugs are the top-selling class of drugs in terms of overall sales, with more than 220 million prescriptions written in the U.S. last year, according to IMS Health, a health-care information company.

The research showed that only 9 out of approximately 64,000 patients taking statins were diagnosed with ALS compared with 10 of 56,000 patients who received placebos during the studies analyzed. In a statement regarding the outcome, the FDA stated, "The results show no increased incidence of the disease in patients treated with a statin compared with placebo.” The total occurrence of ALS in patients treated with statins was 4.2 per 100,000 patient-years and for patients treated with placebo the findings were 5.0 cases per 100,000 patient-years. Based on these findings, the FDA recommended no change in prescribing and using the drugs.

According to Dr. Mark Avigan, director of the Division of Pharmacovigilance in the FDA’s Center for Drug Evaluation and Research, “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.” He said that the finding was reassuring but added, “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.”

ALS is a fatal neurodegenerative disease that usually attacks both upper and lower motor neurons and causes degeneration throughout the brain and spinal cord. As the neurons deteriorate, patients lose their mobility, ability to speak and finally are unable to breathe. About 2 per 100,000 people in the general population are diagnosed with the disease annually with the incidence of ALS increasing with age.

According to the FDA, researchers at Stanford University and health insurer Kaiser Permanente are conducting another study. Results are expected in six to nine months. In addition, the agency is considering additional studies. The current FDA analysis was published in the journal Pharmacoepidemiology and Drug Safety.