While the Medicines Agency has just issued an unfavorable opinion on the marketing of baclofen for the treatment of alcoholism, Amine Benyamina, young department head at the Paul Brousse hospital specializing in addictology and president of the French Federation of addictology, reviews the art and the way to use the controversial product.
Amine Benyamina: By reading the conclusions of the Medicines Agency on baclofen, we had the impression that it had not widened the perimeters of investigation on this drug. A priori, the experts commented on the results which had already prevailed over the decision to restrict the prescription of baclofen to 80 grams. We will see if this analysis is confirmed the day we will be interviewed, at least if that day arrives.
What do you blame the National Medicines Agency for?
Our criticism does not relate to the process itself. When the ANSM assesses baclofen, it is in its role.
It is rather on the fact that the conclusions of the agency 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 on high dosages. .
On this point, the decision taken last summer to reduce the maximum doses of baclofen prescribed to 80 mg / d, against 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 away.
Does Baclofen Effectively Treat Patients With Alcoholism?
He can cure some of them. As we have seen, these are clinical realities. And, it’s important to point out, we don’t need to prescribe high doses to get good feedback.
The message I want to get across to my colleagues is in a way that must be allowed to happen. Baclofen must be allowed to find its patients, which is not the case at the moment.
To treat alcohol addiction, our therapeutic arsenal provides us with many drugs that are neither more nor less effective than baclofen.
Should baclofen be prescribed automatically in cases of alcohol addiction?
No. Already because baclofen is currently only prescribed when traditional treatment strategies are ineffective or inefficient for patients.
Then because to fight against alcoholism, the care must always be medico-social.
The committee considered that Baclofen presented “a potentially increased risk of developing serious adverse events (including deaths, editor’s note) in particular at high doses” and that this could lead “to consider that the benefit-risk ratio is negative “. What side effects have you seen with baclofen in your practice?
On the downside, the side effects of baclofen are mainly the reappearance of withdrawal signs and an increase in the urge to consume alcohol. Be careful, these are psychological side effects, not psychiatric ones.
The side effect of baclofen on the rise is mainly sedation.
Is there a more effective way than all the others to fight alcoholism today?
The only means currently available to effectively combat alcoholism is comprehensive patient care. That is to say, a work of psychology, psychotherapy, a development of the social environment and the taking of drugs which have the authorization of marketing (AMM).
Baclofen or not baclofen, drugs alone cannot cure this disease, which is a multifactorial pathology.
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