1. [Illogical association nalmefene and opioids: Analysis in the French pharmacovigilance database].
- Author
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Favrelière S, Lafay-Chebassier C, Fauconneau B, Quillet A, Yéléhé-Okouma M, Montastruc F, and Pérault-Pochat MC
- Subjects
- Databases, Factual, Drug Labeling, France, Humans, Naltrexone administration & dosage, Pharmacovigilance, Analgesics, Opioid administration & dosage, Methadone administration & dosage, Naltrexone analogs & derivatives, Narcotic Antagonists administration & dosage
- Abstract
Introduction: Nalmefene, an opioid antagonist, causes withdrawal syndromes in patients exposed to an opioid agonist. Despite its contraindication, this illogical drug association persists, especially with opioid substitution drugs (ODS). We measured the benefits of the modification in the summary of product characteristics (SPC) in March 2015 and the package leaflet of Selincro
® in September 2016 on this misuse., Material and Method: We analyzed the observations regarding a use of nalmefene with an opioid between September 2014 and August 2017 in the French pharmacovigilance database and the laboratory., Results: The combination nalmefene and methadone was reported in about half of the cases (46/90). Observations were highest between October 2015 and March 2016 (29/90) and then decreased. Those with self-medication have increased. From October 2016, declarations become rarer., Conclusion: The effect of modifications in the SPC and the package leaflet on the use of nalmefene with ODS was real and progressive., (Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)- Published
- 2019
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