It was the first alcohol dependence drug to go on sale. Monday, June 15, baclofen, marketed under the name of Baclocur, was officially authorized in the treatment of alcoholism . Marketing that put an end to the temporary recommendation for use for other baclofen-based specialties in this indication (Lioresal 10 mg and Baclofen Zentiva 10 mg) “ , then specified the National Agency for the Safety of Medicines and Health Products (ANSM) .
But a reversal of the situation: this authorization was suspended by the courts on Wednesday June 17. It was the Baclohelp collective, which campaigned for the authorization of this drug as part of the treatment of alcoholism, which obtained the suspension of this marketing authorization by a decision of the administrative court of Cergy-Pontoise. And for good reason: they point the finger at the maximum authorized dosage, which they consider too low.
Baclocur: maximum authorized dosage considered too low
This dosage is capped at 80 mg per day, due to the side effects associated with baclofen when this drug is taken in high doses. An inappropriate dosage according to some addictologists, who evoke a “loss of luck” for patients. Associations and people suffering from severe alcohol dependence also regret this maximum dosage: “We are talking about adverse effects but the only ones linked to alcohol are the 45,000 deaths per year” , denounced for example in Le Parisien a 43-year-old woman on baclofen since 2011.
Since this suspension, other baclofen-based drugs may again be prescribed to patients suffering from alcoholism without a legal obligation to limit the dose “until the court rules on the merits of the authorization of marketing issued for Baclocur “ , specifies the administrative court of Cergy-Pontoise in a press release .
What is baclofen?
Baclofen is what is called a “muscle relaxant”, that is to say that it has a relaxing action on the muscles. This medication more specifically treats muscle spasms: it is therefore initially prescribed to patients with multiple sclerosis and certain paralysis, who suffer from painful muscle contractures.
Baclofen was then diverted for use in the treatment of alcoholism. A use which finds its origin in particular in the discovery of the French doctor Olivier Ameisen. After extensive research, this cardiologist, who suffered from alcoholism, administered high doses of baclofen and observed the disappearance of his alcohol dependence . In particular, he told his story in his book The Last Glass, which appeared in 2008.
Baclocur side effects pointed at
A 2017 study by Cnamts, ANSM and Inserm highlighted the risk of intoxication, epilepsy and unexplained death associated with taking high doses of bacflofen. This is why the ANSM has alerted to the possible consequences of this medication, which can impair alertness and thus have consequences for driving vehicles, but also increase the risk of falls, convulsions, respiratory depression and sleep apnea . The health authority has listed the side effects of this medication, including:
- psychiatric conditions, namely restlessness, confusion, attention disorders or mood disorders;
- nervous system conditions, such as drowsiness, sleep disturbance , dizziness, lightheadedness, or memory problems;
- gastrointestinal conditions, including nausea ;
- skin conditions such as hyperhidrosis, that is, excessive production of sweat ;
- musculoskeletal conditions such as myalgia;
- ear conditions like tinnitus ;
- reproductive system and breast disorders.