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FDA: Statins Don’t Increase ALS Risk

September 30, 2008

The U.S. Food and Drug Administration says it has determined statins do not increase the incidence of amyotrophic lateral sclerosis, or Lou Gehrig’s Disease.

The FDA’s review began in 2007 after the agency received a higher-than-expected number of reports of ALS developing in patients taking statins, cholesterol-lowering drugs. But officials said subsequent 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 are the most commonly prescribed medications that treat elevated cholesterol levels in the United States and have also been shown to reduce the risk of heart disease in many patients.

“Based on currently available information, healthcare professionals should not change their prescribing practices for statins and patients should not change their use of statins,” the FDA said.

The agency’s analysis is reported in the journal Pharmacoepidemiology and Drug Safety.




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