[Illogical association nalmefene and opioids: Analysis in the French pharmacovigilance database].

Association illogique nalméfène et opioïdes : analyse dans la base française de pharmacovigilance.

Journal

Therapie
ISSN: 1958-5578
Titre abrégé: Therapie
Pays: France
ID NLM: 0420544

Informations de publication

Date de publication:
Jun 2019
Historique:
received: 13 11 2017
revised: 27 06 2018
accepted: 29 06 2018
pubmed: 11 9 2018
medline: 28 12 2019
entrez: 11 9 2018
Statut: ppublish

Résumé

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 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. 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. The effect of modifications in the SPC and the package leaflet on the use of nalmefene with ODS was real and progressive.

Identifiants

pubmed: 30197228
pii: S0040-5957(18)30128-8
doi: 10.1016/j.therap.2018.06.004
pii:
doi:

Substances chimiques

Analgesics, Opioid 0
Narcotic Antagonists 0
Naltrexone 5S6W795CQM
nalmefene TOV02TDP9I
Methadone UC6VBE7V1Z

Types de publication

Journal Article

Langues

fre

Sous-ensembles de citation

IM

Pagination

369-374

Informations de copyright

Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Auteurs

Sylvie Favrelière (S)

Service de pharmacologie clinique et vigilances, CHU de Poitiers, 86021 Poitiers, France. Electronic address: s.favreliere@chu-poitiers.fr.

Claire Lafay-Chebassier (C)

Service de pharmacologie clinique et vigilances, CHU de Poitiers, 86021 Poitiers, France; Inserm, U1084, université de Poitiers, laboratoire de neurosciences expérimentales et cliniques-LNEC, 86022 Poitiers cedex, France.

Bernard Fauconneau (B)

Service de pharmacologie clinique et vigilances, CHU de Poitiers, 86021 Poitiers, France.

Alexandre Quillet (A)

Service de pharmacologie clinique et vigilances, CHU de Poitiers, 86021 Poitiers, France.

Mélissa Yéléhé-Okouma (M)

Laboratoire de pharmacologie clinique et toxicologie, CHRU de Nancy, 54035 Nancy, France.

François Montastruc (F)

Service de pharmacologie médicale et clinique, pharmacopôle Midi-Pyrénées, faculté de médecine, CHU de Toulouse, 31000 Toulouse, France.

Marie-Christine Pérault-Pochat (MC)

Service de pharmacologie clinique et vigilances, CHU de Poitiers, 86021 Poitiers, France; Inserm, U1084, université de Poitiers, laboratoire de neurosciences expérimentales et cliniques-LNEC, 86022 Poitiers cedex, France.

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Classifications MeSH