Good news this November 25: baclofen (Baclocur) will again be available in pharmacies and hospital pharmacies for the treatment of alcoholism. The Council of State has indeed just canceled the suspension of its marketing which had been ordered last June by the administrative court of Cergy-Pontoise, seized by the association of patients Baclohelp, which considers too low the dose limit imposed for prescribe this medication.
Result of this decision of the Council of State, “lprescription of Baclocur will therefore soon be possible again in accordance with its marketing authorization. (Marketing Authorization) “, assured the Ethypharm laboratory, in a press release.
A little reminder of the facts
Baclofen, a muscle relaxant prescribed illegally for years in a roundabout way to curb the urge to drink, had obtained a temporary authorization for use in 2014. And on June 15, the National Medicines Agency (ANSM) had authorized the final marketing of Baclocur to fight alcoholism.
But, twist, only two days after his arrival at the pharmacy, justice ordered the suspension of its marketing.
“We have been informed by our lawyer that our marketing authorizations were suspended by the courts. This means a cessation of marketing and the withdrawal of batches already on the market”, explained to Parisian Ethypharm, the manufacturer. The ANSM then indicated that it was going to seize the Council of State of an appeal against this decision to suspend in summary proceedings the marketing authorizations of Baclocur specialties (10, 20 and 40 mg). This emergency judgment (summary judgment) results in a return to the previous situation: other baclofen-based drugs can again be prescribed to alcoholic patients, without legal obligation to limit dose, the court explains in a press release. The latter explains his decision by the “risk of interruption of treatment” that the limitation of the doses authorized with Baclocur caused patients who previously took larger quantities of baclofen.
Concretely, the prescriptions issued since June 15 gave rise to a reimbursement conditional on the dosage, that is to say limited to 80mg. “It’s as if we said to diabetics, insulin will now only be reimbursed for the less serious patients. For people with low alcohol dependence, we are happy but for others, we are outraged! case, it is not a victory “, annoyed the president of the Baclohelp collective, Thomas Maës-Martin in the columns of the Parisian on June 18.
A very framed prescription
Before June 15, baclofen had a temporary marketing authorization, but under conditions. Prudente, the Medicines Agency, has always stressed that the benefit / risk balance was not clearly established: on the one hand, sometimes spectacular effects observed in some patients, on the other unwanted effects potentially dangerous. Also, the decision of the Medicines Agency was based above all on the lack of solutions to be offered to alcoholic patients.
“In view of the available data and taking into account the major public health problem represented by alcoholism, the ANSM has decided to grant Marketing Authorization for the specialty BACLOCUR® (baclofen) 10 mg, 20 mg and 40 mg in alcohol dependence, because of the interest in the management of patients in failure therapeutic, by providing for reinforced monitoring as soon as it is marketed “ underlined in 2018 the Medicines Agency.
For this reason, the prescription has always been framed. Baclocur drug should be dispensed by a physician at the “lowest dose for good therapeutic response and acceptable tolerance”. But the maximum dosage cannot not exceed 80mg / day. In addition, prescription is only possible if other treatments tried previously have failed. The patient must also be followed by a professional or a specialized hospital service.
Indispensable precautions which are based on an expertise conducted by the ANSM according to which high-dose adverse effects had been identified (psychiatric disorders, asthenia, nervous system disorders, etc.). The drug also has an increased risk of serious side effects (and death) at high doses.
Recall that this drug began to arouse the interest of the medical community and associations in 2008, when the book was published. The last drink by Olivier Ameisen, cardiologist today deceased. The doctor, who prescribed it for himself, explained how baclofen had enabled him to end his alcohol addiction.
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