FDA Study Shows No Link Between Use of Statins and ALS

By Aaron Poehler

Published on September 30, 2008

The U.S. Food and Drug Administration (FDA) released an analysis of the results of 41 clinical trials today which demonstrates that use of statins does not increase the risk of amyotrophic lateral sclerosis (ALS).

The analysis showed that out of approximately 64,000 patients who were prescribed statins, only nine were diagnosed with ALS during the time period of the studies, compared with 10 of approximately 56,000 patients given placebos. Based on the findings of the analysis, FDA officials recommended no change in prescription or use of statin drugs.

The analysis was begun when FDA officials noted that the agency's Adverse Event Reporting System received a higher than expected number of reports of ALS, also known as Lou Gehrig's disease, appearing in patients who received with cholesterol-lowering statin drugs. Statins are a class of medications which are frequently prescribed to lower cholesterol and reduce risks of heart disease, and are considered among the most effective in reducing elevated levels of LDL cholesterol. Among the most common statin drugs are Pfizer's Lipitor, AstraZeneca's Crestor, Merck & Company's Zocor, and Bristol-Myers Squibb Company's Pravachol. In terms of overall sales, statins were the top-selling class of drugs in 2007.

About two per 100,000 people are diagnosed each year with ALS, a generally fatal neurodegenerative disease that attacks motor neurons which control voluntary movement, leading to muscle weakness, atrophy, and degeneration of the brain and spinal cord.

 

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