Used in the treatment of spasticity at low doses, baclofen is also prescribed off-label at high doses for the treatment of alcohol dependence. Several cases of baclofen intoxication have been reported, but only 1 case deals with the treatment of alcohol dependence. Thus, we report the first death in the context of baclofen off-label use of an alcohol-dependent patient with a high blood baclofen concentration after intentional drug intoxication. The safety profile of baclofen in the treatment of alcohol dependence is reviewed and discussed, underlining the obligatory caution that may support any prescription of high doses of baclofen in this off-label indication and especially in patients with concomitant psychiatric disorders.

Keywords:
Baclofen, Intoxication, Death, Alcohol dependence
1.
Verrotti A, Greco R, Spalice A, Chiarelli F, Iannetti P: Pharmacotherapy of spasticity in children with cerebral palsy. Pediatr Neurol 2006;34:1-6.
2.
Colombo G, Agabio R, Carai MA, Lobina C, Pani M, Reali R, Addolorato G, Gessa GL: Ability of baclofen in reducing alcohol intake and withdrawal severity. I. Preclinical evidence. Alcohol Clin Exp Res 2000;24:58-66.
3.
Addolorato G, Caputo F, Capristo E, Colombo G, Gessa GL, Gasbarrini G: Ability of baclofen in reducing alcohol craving and intake. II. Preliminary clinical evidence. Alcohol Clin Exp Res 2000;24:67-71.
4.
Ameisen O: Complete and prolonged suppression of symptoms and consequences of alcohol-dependence using high-dose baclofen: a self-case report of a physician. Alcohol Alcohol 2005;40:147-150.
5.
Ameisen O: Le dernier verre. Paris, Denoël, 2008.
6.
Comité de coordination de Toxicovigilance, Groupe de travail ‘Médicament': Impact sur le nombre de cas d'exposition notifiés aux CAPTV et leur gravité de l'éventuelle utilisation hors AMM de spécialités à base de baclofène (rapport fait à la demande de l'ANSM). 2012. http://www.centres-antipoison.net (accessed July 31, 2013).
7.
ANSM: Mise en garde sur l'utilisation hors AMM du baclofène dans le traitement de l'alcoolo-dépendance. 2011. http://ansm.sante.fr (accessed July 31, 2013).
8.
ANSM: Utilisation du baclofène dans le traitement de l'alcoolo-dépendance: actualisation. 2012. http://ansm.sante.fr (accessed July 31, 2013).
9.
ANSM: Baclofène et traitement de l'alcoolo-dépendance : l'ANSM autorise deux essais cliniques - Point d'information. 2012. http://ansm.sante.fr (accessed July 31, 2013).
10.
Villier C, Schir E, Mallaret M: Effets indésirables du baclofène dans le traitement des addictions - Suivi national de pharmacovigilance: année 2011. 2012. http://ansm.sante.fr (accessed July 31, 2013).
11.
VanDierendonk DR, Dire DJ: Baclofen and ethanol ingestion: a case report. J Emerg Med 1999;17:989-993.
12.
De Giovanni N, d'Aloja E: Death due to baclofen and dipyrone ingestion. Forensic Sci Int 2001;123:26-32.
13.
Chong CF, Wang TL: An unusual presentation of baclofen overdose. Emerg Med J 2005;22:673-674.
14.
Kumar G, Sahaya K, Goyal MK, Sivaraman M, Sahota PK: Electroencephalographic abnormalities in baclofen-induced encephalopathy. J Clin Neurosci 2010;17:1594-1596.
15.
Hsieh MJ, Chen SC, Weng TI, Fang CC, Tsai TJ: Treating baclofen overdose by hemodialysis. Am J Emerg Med 2012;30:1654.e5-e7.
16.
Sullivan R, Hodgman MJ, Kao L, Tormoehlen LM: Baclofen overdose mimicking brain death. Clin Toxicol (Phila) 2012;50:141-144.
17.
Comité de coordination de Toxicovigilance. Cas d'exposition au baclofène: données des centres antipoison et de toxicovigilance, 2003-2007 (rapport fait à la demande de l'ANSM). 2009. http://www.centres-antipoison.net (accessed July 31, 2013).
18.
Vidal 2013: Le dictionnaire. Liorésal® 10 mg comprimé. Paris, Vidal, 2013.
19.
Marsot A, Imbert B, Alvarez JC, Grassin- Delyle S, Jaquet I, Lançon C, Simon N: High variability in the exposure of baclofen in alcohol-dependent patients. Alcohol Clin Exp Res 2014;38:316-321.
20.
Gégu C, Gagnon N, Schmitt C, Tichadou L, Hayek-Lanthois M, De Haro L: High-dose baclofen treatment-induced overdose in a chronic ethylic patient with renal insufficiency. Therapie 2012;67:529-531.
21.
Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G: Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet 2007;370:1915-1922.
22.
Garbutt JC, Kampov-Polevoy AB, Gallop R, Kalka-Juhl L, Flannery BA: Efficacy and safety of baclofen for alcohol dependence: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res 2010;34:1849-1857.
23.
Addolorato G, Leggio L, Ferrulli A, Cardone S, Bedogni G, Caputo F, Gasbarrini G, Landolfi R; Baclofen Study Group: Dose-response effect of baclofen in reducing daily alcohol intake in alcohol dependence: secondary analysis of a randomized, double-blind, placebo-controlled trial. Alcohol Alcohol 2011;46:312-317.
24.
Rigal L, Alexandre-Dubroeucq C, de Beaurepaire R, Le Jeunne C, Jaury P: Abstinence and ‘low-risk' consumption 1 year after the initiation of high-dose baclofen: a retrospective study among ‘high-risk' drinkers. Alcohol Alcohol 2012;47:439-442.
25.
de Beaurepaire R: Suppression of alcohol dependence using baclofen: a 2-year observational study of 100 patients. Front Psychiatry 2012;3:103.
26.
Morley KC, Leung S, Baillie A, Haber PS: The efficacy and biobehavioural basis of baclofen in the treatment of alcoholic liver disease (BacALD): study protocol for a randomised controlled trial. Contemp Clin Trials 2013;36:348-355.
27.
ClinicalTrials.gov: Identifier NCT01266655, Baclofen for the Treatment of Alcohol Dependence (BACLAD). December 23, 2010 (cited February 14, 2014). http://clinicaltrials.gov/ct2/show/NCT01266655?term=baclad&rank=1.
28.
Dasarwar N, Shanbag P, Kumbhare N: Baclofen intoxication after accidental ingestion in a 3-year-old child. Indian J Pharmacol 2009;41:89-90.
29.
Weißhaar GF, Hoemberg M, Bender K, Bangen U, Herkenrath P, Eifinger F, Rothschild M, Roth B, Oberthuer A: Baclofen intoxication: a ‘fun drug' causing deep coma and nonconvulsive status epilepticus - a case report and review of the literature. Eur J Pediatr 2012;171:1541-1547.
30.
Hazell L, Shakir SA: Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006;29:385-396.
31.
Agabio R, Preti A, Gessa GL: Efficacy and tolerability of baclofen in substance use disorders: a systematic review. Eur Addict Res 2013;19:325-345.
32.
Rolland B, Deheul S, Danel T, Bordet R, Cottencin O: A system of prescriptions without drug approval: example of baclofen. Therapie 2010;65:511-518.
© 2014 S. Karger AG, Basel
2014
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.