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Amiodarone and Parkinsonism: a pharmacovigilance study
Jean-Louis Montastruc1, Geneviève Durrieu1
1Service de Pharmacologie Médicale et Clinique, Centre de PharmacoVigilance, de Pharmaco-épidémiologie et d'Informations sur le Médicament de Toulouse, CIC INSERM 1426, Faculté de Médecine, Centre Hospitalier Universitaire, Toulouse, France.
Fundamental & Clinical Pharmacology
|October 24, 2020
Summary
This study found no link between amiodarone and parkinsonism. Reports of parkinsonism with amiodarone may stem from other causes, not the drug itself.
Area of Science:
- Pharmacovigilance and Drug Safety
- Neurology and Clinical Pharmacology
Background:
- Previous case reports suggested a link between amiodarone and parkinsonism.
- This study aimed to investigate the potential association between amiodarone exposure and parkinsonism.
Purpose of the Study:
- To evaluate the association between amiodarone and parkinsonism using a large pharmacovigilance database.
- To determine if the potential association is influenced by sex, time period, or concomitant medications.
Main Methods:
- Utilized the World Health Organization's VigiBase pharmacovigilance database.
- Conducted disproportionality analyses (ROR, IC) on adverse drug reactions reporting 'Parkinson-like events' with amiodarone.
- Performed analyses on the entire dataset, stratified by sex, limited to the last two decades, and after excluding confounding medications.
Main Results:
- No significant association between amiodarone and parkinsonism was detected in the overall population.
- Subgroup analyses, including by sex, time period (2000-2019), and after excluding known parkinsonism-inducing drugs, also showed no significant association.
- The reporting odds ratio (ROR) was 0.83 (95% CI: 0.65-1.06).
Conclusions:
- The study failed to identify a safety signal for parkinsonism associated with amiodarone use.
- Existing reports of parkinsonism in patients taking amiodarone are likely attributable to other underlying medical conditions or factors.
- Further investigation into alternative explanations for reported cases is warranted.
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