The ANSM has decided to authorize the marketing of baclofen to fight against alcoholism. Its prescription is controversial.
ANSM has decided to grant marketing authorization for BACLOCUR® (baclofen) 10 mg, 20 mg and 40 mg in alcohol dependence, for the management of patients experiencing treatment failure, and providing for follow-up reinforced from the moment it is marketed.
“Baclofen is indicated in the reduction of alcohol consumption, in addition to psychosocial monitoring, after failure of other treatments, in adults”, specifies the public health agency. The treatment cannot therefore be prescribed as first-line treatment and will have a maximum dosage of 80 mg/day, which is low compared to what could be consumed previously by certain patients.
Reinforced follow-up
“The agency’s conclusions do not take into account the importance of the prescription of baclofen in France and the importance of the stability that a certain number of patients had who were under high dosages”, deplores on this subject Amine Benyamina, young head of department at the Paul Brousse hospital specializing in addictology and president of the French Federation of addictology. “The decision that was taken last summer to reduce the maximum doses of baclofen prescribed to 80 mg/d (compared to 300 mg/d previously) did not sufficiently take into account the reality on the ground. The experts who make up the ANSM committee are too far from it,” he adds.
In this sense, reinforced monitoring of baclofen is planned as soon as it is marketed. On the basis of this monitoring and the evolution of available scientific data, the ANSM may have to revise the conditions of use of baclofen. “The only way we currently have to fight alcoholism effectively is to take global care of the patient. That is to say work in psychology, psychotherapy, adjustment of the social environment and taking drugs that have marketing authorization. Baclofen or no baclofen, drugs alone cannot overcome this disease, which is a multifactorial pathology”, further specifies Amine Benyamina.
Controversial
The controversy surrounding the use of Baclofen as a treatment for alcoholism began in July 2017, when the ANSM published a study co-directed by the National Health Insurance Fund (CNAM) and Inserm, concluding that the The drug’s safety level was “concerning” when used at high doses in people with alcoholism. In the process, the ANSM had reduced the prescription dose to 80 mg per day, against 300 mg previously “given the increased risk of hospitalization and death”.
Initially prescribed as a muscle relaxant as part of a treatment against multiple sclerosis, Baclofen has gradually been used to treat alcoholism.
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