[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: Benjamin Rolland, Sylvie Deheul, Alexandre Louvet, Sophie Gautier, Olivier Cottencin, Régis Bordet, le dispositif CAMTEA
• Journal: Therapie (Therapie) 2014 Mar-Apr Vol. 69 Issue 2 Pg. 143-7 ISSN: 0040-5957 [Print] France
• Vernacular Title: Baclofène et cirrhose : analyse de la littérature et précautions d'emploi adoptées au sein du dispositif CAMTEA.
• PMID: 24926632 (Publication Type: English Abstract, Journal Article, Review)
• Copyright: © 2014 Société Française de Pharmacologie et de Thérapeutique.

Chemical References

• GABA-B Receptor Agonists
• Baclofen

Topics

• Alcoholism (complications, drug therapy)
• Baclofen (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• France
• GABA-B Receptor Agonists (administration & dosage, adverse effects)
• Gastrointestinal Diseases (chemically induced)
• Hepatic Encephalopathy (chemically induced)
• Humans
• Interdisciplinary Communication
• Liver Cirrhosis (chemically induced)
• Off-Label Use
• Pharmacovigilance
• Referral and Consultation (legislation & jurisprudence, organization & administration)