Statins, Neuromuscular Degenerative Disease and an Amyotrophic Lateral Sclerosis-Like Syndrome:

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Statins, Neuromuscular Degenerative Disease and an Amyotrophic Lateral

Sclerosis-Like Syndrome: An Analysis of Individual Case Safety Reports from

Vigibase.

 

Short Communication

 

Drug Safety. 30(6):515-525, 2007.

Edwards, I Ralph; Star, Kristina; Kiuru, Anne

Abstract:

Background: The WHO Foundation Collaborating Centre for International Drug

Monitoring (Uppsala Monitoring Centre [uMC]) has received many individual

case safety reports (ICSRs) associating HMG-CoA reductase inhibitor drug

(statin) use with the occurrence of muscle damage, including rhabdomyolysis,

and also peripheral neuropathy. A new signal has now appeared of

disproportionally high reporting of upper motor neurone lesions.

 

Aim and Scope: The aim of this paper is to present the upper motor neurone

lesion cases, with other evidence, as a signal of a relationship between

statins and an amyotrophic lateral sclerosis (ALS)-like syndrome. The paper

also presents some arguments for considering that a spectrum of severe

neuromuscular damage may be associated with statin use, albeit rarely. The

paper does not do more than raise the signal for further work and analysis

of what must be regarded as a potentially very serious and perhaps avoidable

or reversible adverse reaction, though it also suggests action to be taken

if an ALS-like syndrome should occur in a patient using statins.