Immediately announced, immediately withdrawn. After more than ten years, it was believed the saga medical Baclofen finally over. But it was without counting on an ultimate coup de théâtre. Then for the first time, a drug against alcoholism at the base of this molecule is controversial, the Baclocur, had to be authorized in France Monday, this Wednesday, the justice has just stopped : “We learn that our authorisations for placing on the market are suspended, we announced Ethypharm, the manufacturer. Which means the stop of the marketing and the withdrawal of the lots already on the market. For the moment, we do not know if they are all concerned. “
While this new tablet had been put up for sale on order, a court decision was, at the same time, very expected. The collective Baclohelp had, indeed, filed a petition for suspension to the administrative court of Cergy-Pontoise (Val-d’oise). The reason for their discontent ? The dose of the treatment is limited to 80 mg per day, as decided by the constable of the drug (MSNA). These restrictions had been taken after a study of health insurance in 2017, citing ” increased risks of hospitalization and death in high doses. However, this risk is not proven according to the experts, and the quantity is insufficient to allow two-thirds of them to get rid of the alcohol.
As a reminder, Baclofen, a relaxant muscle had been prescribed illegally for years before receiving a temporary authorization in 2014. In this framework, different dosages up to 300 mg per day, were allowed if the patient’s health demanded it. This was no longer the case with this new tablet, the Baclocur.
“This is good news “
This Wednesday evening, the judges pronounced in favour of the suspension of the placing on the market of this new tablet. It ” could be an obstacle to the continuation of treatment at doses greater than 80 mg “, according to the order, that we have been able to consult. “There is a very high risk of rupture, therefore, that pharmacists no longer want to deliver Baclofen-Zentiva for the alcoolodépendance in the absence of a temporary recommendation of use “.
“This is good news ! Reacts Thomas Maës-Martin, founder of the association, to the origin of this referred. Patients will be able to continue their treatment at the dosage prescribed by their doctor, between 80 and 300 mg, according to their needs. “For many, this pill has changed their lives, cutting off any desire to drink. Contacted, the drug Agency has not responded to our requests.