Cholesterol-lowering drugs or statins do not increase the incidence of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’ disease, according to an analysis made by the Food and Drug Administration, which was published on the Sept 29 issue of the journal Pharmacoepidemiology and Drug Safety.

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The degeneration of the motor neurons in ALS eventually leads to death. When the neurons die, the ability of the brain to initiate and control muscle movement is lost, resulting in paralysis. The disease was named after the baseball player, Lou Gehrig who played for the New York Yankees and died in 1941 because of it. The disease affects between 1 and 2 people in 100,000 and there is no known treatment for it. According to the ALS Association, about 5,600 people in the United States are diagnosed with ALS each year.

Statins are usually prescribed to reduce heart risk in people with underlying heart conditions by lowering the amount of cholesterol in the blood. The drugs work by blocking the enzyme HMG-CoA-reductase, which is needed by the body to make cholesterol. The most common adverse side effects found to be associated with the use of statins include muscle pain and muscle weakness.

The FDA conducted an analysis of 41 long-term controlled clinical trials to see whether statins really increase risk of ALS, as several studies point to an interrelation between ALS and Tau phosphorylation protein induced in abnormal levels by statins.

The FDA found that nine out of about 64,000 patients treated with statins were diagnosed with ALS during the trials compared with 10 of 56,000 patients given placebos.

“The results show no increased incidence of the disease in patients treated with a statin compared with placebo,” the FDA said in a statement on Monday. Therefore, the FDA recommended no change in prescribing and using of statins. However reassuring these findings are, Mark Avigan, head of the FDA's Division of Pharmacovigilance I, said “continued study of this issue is warranted,” given the “serious nature” of ALS.

Statins currently available in the United States include Pfiser Inc.’s Lipidor, Merck & Co. Inc’s Zocor and Mevacor; AstraZeneca Plc’s Crestor, Bristol-Myers Squibb Co.’s Pravachol and Novartis’ Lescol.

Besides reducing heart risk, statins were shown to slow down age-related memory loss and dementia as well. A study published in July 29 issue of the journal Neurology involving 1,674 elderly people showed that those taking cholesterol-lowering drugs were about half as likely to develop dementia over five years of follow-up compared to those who did not. This is an important step forward in understanding Alzheimer’s disease and in finding treatments for delaying its devastating symptoms. However, researchers advise people to only take statins when medically competent personnel instruct them to do so.