title: [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].
abstract: Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.
authors.affiliation: 1 Regionales Pharmacovigilance Zentrum, Klinik für Klinische Pharmakologie und Toxikologie, Universitätsspital Zürich und Universität Zürich.
authors.forename: Hendrike
authors.initials: H
authors.lastname: Dahmke
authors.affiliation: 1 Regionales Pharmacovigilance Zentrum, Klinik für Klinische Pharmakologie und Toxikologie, Universitätsspital Zürich und Universität Zürich.|2 Tox Info Suisse, Assoziiertes Institut der Universität Zürich.
authors.forename: Hugo
authors.initials: H
authors.lastname: Kupferschmidt
authors.affiliation: 1 Regionales Pharmacovigilance Zentrum, Klinik für Klinische Pharmakologie und Toxikologie, Universitätsspital Zürich und Universität Zürich.
authors.forename: Gerd A
authors.initials: GA
authors.lastname: Kullak-Ublick
authors.affiliation: 1 Regionales Pharmacovigilance Zentrum, Klinik für Klinische Pharmakologie und Toxikologie, Universitätsspital Zürich und Universität Zürich.
authors.forename: Stefan
authors.initials: S
authors.lastname: Weiler
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000437:Alcoholism / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008691:Methadone; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D010098:Oxycodone; D060735:Pharmacovigilance; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis*
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone; D010098:Oxycodone; C038981:nalmefene; D008691:Methadone
keywords: Alkoholabhängigkeit; Arzneimittelinteraktion; Entzugssymptome; Entzugssyndrom; Opioidrezeptoren; alcohol dependence; drug-drug interaction; dépendance à l’alcool; interactions médicamenteuses; opioid receptors; récepteurs opioïdes; symptômes de sevrage; syndrome de sevrage; withdrawal symptoms; withdrawal syndrome