Statins and ALS-like syndrome



Drug Saf. 2007;30(6):515-25.

Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase.Edwards IR, Star K, Kiuru A.
The WHO Foundation Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), Uppsala, Sweden.

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.

METHODS: The 43 reports accounting for the disproportional reports in Vigibase (the database of the WHO Programme for International Drug Monitoring) are summarised and analysed for the diagnosis of an ALS-like syndrome. The issues of data quality and potential reporting bias are considered. RESULTS: 'Upper motor neurone lesion' is a rare adverse event reported in relationship to drugs in Vigibase (a database containing nearly 4 million ICSRs). Of the total of 172 ICSRs on this reported term, 43 were related to statins, of which 40 were considered further: all but one case was reported as ALS. In 34/40 reports a statin was the sole reported suspected drug. The diagnostic criteria were variable, and seven of the statin cases also had features of peripheral neuropathy. Of a total of 5534 ICSRs of peripheral neuropathy related to any drug in Vigibase, 547 were on statins. The disproportional reporting of statins and upper motor neurone lesion persisted after age stratification, and such disproportionality was not seen for statins and Parkinson's disease, Alzheimer's disease, extrapyramidal disorders, or multiple sclerosis-like syndromes.

The disproportionally high reporting makes this an important signal nevertheless, since ALS is serious clinically and statins are so widely used. Wide use of the statins also makes a chance finding more probable, but is unlikely to cause disproportional reporting when there are no obvious biases identified.

CONCLUSION: We emphasise the rarity of this possible association, and also the need for further study to establish whether a causal relationship exists. We do advocate that trial discontinuation of a statin should be considered in patients with serious neuromuscular disease such as the ALS-like syndrome, given the poor prognosis and a possibility that progression of the disease may be halted or even reversed.

PMID: 17536877 [PubMed - in process]

I sure hope they do the research and find a connection as it will save many llives.

I normally post in the Peripheral Neuropathy forum, but noticed this thread and was very interested in it.

My dad, age 86, has been on statins now for at least 2 years. I CANNOT get him to quit taking them. He is of the generation who still think that doctors have the answers to everything and would never prescribe anything that might cause problems.

Well, I think they are causing problems. I have read numerous reports on the Internet about muscle weakness, despite normal enzymes indicating damage. His bloodwork is normal...

He is so weak, that yesterday when I spoke with him, long distance, he was unable to get up off of the bed. AT 86, I know it is normal to weaken, but this is terrible. He and his wife have always played golf, walked, traveled extensively and they were swimming every week... All of that has stopped.

Any suggestions here? I am copying this article to mail to him, since he is not very Internet savy. I hope that some others might come along and post a response here. Perhaps he will listen if he hears this from someone else.

Thanks, and have a good day,

Cathie

Hi Kathie, you may be interested in accessing a web site developed and maintained by Dr. Duane Graveline, MD. He is a family physician who trained as a NASA astronaut; he developed temoprary global amnesia from lipitor, and has devoted his time and energies to the study of adverse effects of statins. one of the points he makes over and over again is that statins have not been proven to be of benefit to the elderly or to women. muscle weakness is the most common complaint and peripheral neuropathy figures prominently in the list of complaints. his web site is: spacedoc.net. best of luck to you and your dad.

Thank you for this website. I have already forwarded a copy of the above to my dad and will follow with this link.

My best to all of you here. You have an amazing forum...
Cathie