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No Increased Risk for ALS with Statins, FDA Says
Statins likely do not pose increased risk for developing amyotrophic lateral sclerosis (ALS), according to an FDA analysis published online in Pharmacoepidemiology and Drug Safety.
From 1991 to 2006, the agency received 57 reports of ALS in U.S. patients taking statins, triggering the analysis. However, using population estimates and pharmacy records, the researchers determined that this number was similar to that expected. And, after examining data from 41 controlled clinical trials, they found that ALS incidence rates were 4.2 per 100,000 person-years in patients taking statins versus 5.0 per 100,000 person-years in those on placebo.
Although the authors say they could not rule out the possibility that statins may reveal or exacerbate muscle weakness associated with ALS, they conclude that "the weight of evidence ... argues against the possibility that treatment with statins initiates this neurodegenerative disorder."
The FDA says it's expecting further data, but in the meantime, practice patterns shouldn't be changed.
LINK(S):
Pharmacoepidemiology and Drug Safety article (Free abstract; full text requires subscription)
FDA news release (Free)
Published in Physician's First Watch September 30, 2008
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