Statin‐induced myasthenia: A disproportionality analysis of the WHO's VigiBase pharmacovigilance database

Background Statins have been linked to myasthenia gravis (MG) in recent case reports. However, MG is not currently listed as an adverse drug reaction (ADR) in the summary of product characteristics. Methods We performed case/noncase analyses in VigiBase® (the World Health Organization international...

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Bibliographic Details
Published in:Muscle & nerve 2019-10, Vol.60 (4), p.382-386
Main Authors: Gras‐Champel, Valerie, Batteux, Benjamin, Masmoudi, Kamel, Liabeuf, Sophie
Format: Article
Language:English
Subjects:
Adult
adverse drug reaction
Aged
Aged, 80 and over
Case reports
Case-Control Studies
Confidence intervals
Databases, Factual
disproportionality
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
Life Sciences
Male
Middle Aged
Myasthenia
Myasthenia gravis
Myasthenia Gravis - chemically induced
Neuromuscular junctions
Pharmacovigilance
statin
Statins
World Health Organization
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Summary:Background Statins have been linked to myasthenia gravis (MG) in recent case reports. However, MG is not currently listed as an adverse drug reaction (ADR) in the summary of product characteristics. Methods We performed case/noncase analyses in VigiBase® (the World Health Organization international database of suspected ADR) to identify a signal of MG (expressed as the reporting odds ratio [ROR] and its 95% confidence interval [CI]) for statins. Results A total of 3967 reports mentioned MG. Of these, 169 were suspected to be statin‐induced. A disproportionality signal was found for MG and statins use (ROR [95%CI] = 2.66 [2.28–3.10]). Conclusions The present disproportionality analysis revealed a possible drug safety signal linking MG and statins. This potential signal is weak, and is offset by the cardiovascular benefits of statins. Clinicians should be aware of this potential ADR, because it may require consideration of statin withdrawal or treatment of MG.
ISSN:0148-639X
1097-4598
DOI:10.1002/mus.26637