Statin-induced myasthenia: A disproportionality analysis of the WHO's VigiBase pharmacovigilance database.
adverse drug reaction
disproportionality
myasthenia
pharmacovigilance
statin
Journal
Muscle & nerve
ISSN: 1097-4598
Titre abrégé: Muscle Nerve
Pays: United States
ID NLM: 7803146
Informations de publication
Date de publication:
10 2019
10 2019
Historique:
received:
02
08
2018
revised:
24
04
2019
accepted:
09
07
2019
pubmed:
13
7
2019
medline:
15
1
2020
entrez:
13
7
2019
Statut:
ppublish
Résumé
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. 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. 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]). 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.
Sections du résumé
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.
Substances chimiques
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
382-386Informations de copyright
© 2019 Wiley Periodicals, Inc.
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