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Alcohol dependence: the risks of high-dose baclofen

With high-dose baclofen, there is an increased risk of epilepsy, infection, myocardial infarction or suicidal thoughts.

Baclofen has been used as a muscle relaxant since the 1970s. In France, it has also been used orally since the 2000s, at higher doses, to reduce alcohol consumption or to help maintain abstinence among alcohol-dependent patients.

At present, its use in alcohol dependence is governed by a temporary recommendation for use issued by the French Health Products Safety Agency (Agence française du médicament, ANSM).

In July 2017, the ANSM reduced the maximum dose of baclofen in alcohol dependence from 300 mg to 80 mg per day. This reduction follows the publication of the results of a French pharmaco-epidemiological study involving more than 200 000 patients. They showed an increased dose-dependent risk of hospitalisation and death with high doses of baclofen, compared to the risk from other alcohol-dependence drugs.

The results of this study highlight the need, in the event of exposure to high-dose oral baclofen, to be particularly aware of the risk, in the event of exposure to high-dose oral baclofen, of epilepsy, infections, myocardial infarction and suicidal thoughts. They also reinforce the need for evidence of the efficacy of high doses to justify taking such risks.

©Prescrire 1 November 2018

"High-dose baclofen and alcohol dependence: hospitalisations and deaths" Prescrire Int 2018; 27 (198): 266-268. (Pdf, subscribers only).

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See also:

Baclofen and severe alcohol
dependence: an uncertain
harm-benefit balance
as of early 2013
September 2013

Role of medications
in the management
of alcohol dependence
Prescrire Int 2013;
22 (141): 217.
Pdf, subscribers only

Alcohol withdrawal syndrome:
preventive measures.
Prescrire Int 2015;
24 (166): 300-301.
Pdf, subscribers only

High-dose baclofen:
withdrawal syndrome following
abrupt discontinuation
Prescrire Int 2014;
23 (153): 241.
Pdf, subscribers only