Baclofen : the new assay at the heart of a controversy
Published the 13.07.2017 at 13: 13
The end of the honeymoon would it have sounded to the baclofen ? Hailed by addictologues, this drug is suspected to reduce the addiction to alcohol. But clinical trials, showing a minor impact followed. High doses, however, are administered.
More worryingly, the most recent study showed an increased risk of hospitalization and death in more than 75 mg per day. These results have prompted the national security Agency of the drug (MSNA) to review its strategy.
The Recommendation Temporary Use (RTU), in force since 2014, has been revised. Now, doctors will not prescribe more than 80 mg of baclofen per day. What arouses anger and misunderstanding on the side of the practitioners.
A difficult transition
On the side of the addictologues, the concern that dominates. According to the study conducted by Inserm and the national health Insurance Fund, 1 % of patients only take doses of bacofène higher than 180 mg per day. And only 9 % use of high doses.
But the specialists of alcohol dependence, fear that the transition to the new dosage is difficult. Or even dangerous. “The decay of the doses can only be done gradually, omen the branch general of the Federation Addiction in a press release. A number of general practitioners will continue to prescribe, outside the RTU and off-label, the sufficient doses of baclofen “.
Patients will then be outside of any pharmacovigilance system, which presents a real risk. In the state, the association regrets that the results of the latest study, Bacloville, are not expected.
49 000 deaths per year
The reduction of the maximum dose could also have a counter-productive effect, according to MG Addiction. In the absence of appropriate treatment, patients will continue their consumption risk. And the damage caused by the alcohol will leave no room for controversy.
Each year, 49 000 premature deaths are related to this substance. “The consequences of the absence of treatment at effective dose (…) are heavier than the disadvantages of the baclofen,” said MG Addiction.
Beyond the decision of the MAN, it is the study of the origin of this revision, which is under the fire of criticism. The specialists of the addiction point to a major flaw : it does not relate to the patients included in the RTU.