| Hans-Günter Meyer-Thompson | Alkohol
CSST “Evaluation of the benefit/risk ratio of the use of baclofen in alcohol-dependent patients” - Statement of opinion - 17/04/2018
CSST “Evaluation of the benefit/risk ratio of the use of baclofen in alcohol-dependent patients” - Statement of opinion - 17/04/2018
In summary, the efficacy of Baclofen in the reduction of alcohol consumption in adult patients with alcohol dependence and high drinking risk level, as demonstrated in the present application, was judged clinically insufficient. This, in addition to a potentially increased risk of developing serious adverse events (including death) especially at high doses, leads to consider that the benefit risk balance is negative. (ansm – Agence nationale de sécurité du médicament et des produits de santé, Frankreich, 17.04.2018)