title: [Baclofen and liver cirrhosis: literature review and safety precautions implemented within the system CAMTEA].
abstract: The off-label prescribing of high dose baclofen (HDB) has been recently spreading in France. The impact of HDB on subjects with liver cirrhosis remains poorly known. The main pharmacodynamic and pharmacokinetic data on baclofen result from studies on healthy subjects or using low doses of treatment. The specific biodisponibility and elimination of HDB have not been studied yet in cirrhosis. National pharmacovigilance reports suggest that a careful use of baclofen or even HDB could be possible in compensated cirrhosis. However, theoretical risks of baclofen overdose exist in cases of hepatorenal syndrome or portosystemic shunt. Baclofen could also induce a specific pharmacological potentiation of hepatic encephalopathy and gastropathy. Within CAMTEA, a regional team-based multidisciplinary system for delivering and monitoring off-label medications in alcohol use disorders, a set of predefined precautions for using baclofen in cirrhosis have been implemented, until further information becomes available. These precautions notably consist of a protocolized process for declaring adverse events, and a hepatologic follow-up associated with the usual multidisciplinary care system set up within CAMTEA.
authors.affiliation: Dispositif CAMTEA, CHU Lille, Lille, France - Service d'Addictologie, CHU Lille, Lille, France - Université Lille Nord de France, Lille, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Rolland
authors.affiliation: Dispositif CAMTEA, CHU Lille, Lille, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Deheul
authors.affiliation: Service de Gastro-entérologie, CHU Lille, Lille, France - Université Lille Nord de France, Lille, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Louvet
authors.affiliation: Service de Pharmacovigilance, CHU Lille, Lille, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gautier
authors.affiliation: Dispositif CAMTEA, CHU Lille, Lille, France - Service d'Addictologie, CHU Lille, Lille, France - Université Lille Nord de France, Lille, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Cottencin
authors.affiliation: Dispositif CAMTEA, CHU Lille, Lille, France - Université Lille Nord de France, Lille, France.
authors.forename: Régis
authors.initials: R
authors.lastname: Bordet
mesh_terms: D000437:Alcoholism / Q000150:complications / Q000188:drug therapy*; D001418:Baclofen / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005602:France; D058786:GABA-B Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects*; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006501:Hepatic Encephalopathy / Q000139:chemically induced; D006801:Humans; D033183:Interdisciplinary Communication; D008103:Liver Cirrhosis / Q000139:chemically induced*; D056687:Off-Label Use; D060735:Pharmacovigilance; D012017:Referral and Consultation / Q000331:legislation & jurisprudence / Q000458:organization & administration
chemical_list: D058786:GABA-B Receptor Agonists; D001418:Baclofen