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L'Agence Nationale de Sécurité du Médicament lance une mise en garde contre le tétrazépam.

Ce produit, fréquemment utilisé pour combattre les contractures musculaires douloureuses, provoque des effets indésirables cutanés qui peuvent être graves.
Commercialisé depuis 1969, le tétrazépam fait partie des benzodiazépines. Il est prescrit par les généralistes et les rhumatologues pour ses propriétés myorelaxantes (permettant aux muscles de se relâcher). Le plus connu est le Myolastan.

C'est une longue enquête de pharmacovigilance, démarrée dès le lancement du produit et qui s'est terminée en juin 2012, qui a répertorié 1616 effets indésirables, dont 648 qualifiés de « graves » : le tétrazépam peut provoquer des problèmes de peau, mais aussi des troubles psychiatriques et neurologiques. Les troubles cutanés constituent cependant le risque majeur (805 effets indésirables sur 1616), l'enquête révélant « une fréquence élevée d'effets indésirables cutanés (...) tels que des syndromes de Lyell et de Stevens-Jhonson et des syndromes d'hypersensibilité médicamenteuse (DRESS). 11 décès sont attribués à ce médicament.

L'ANSM a saisi donc l'Agence Européenne du Médicament (AEM) pour lui « recommander la réévaluation du rapport bénéfice-risque de ce médicament et la suspension de son Autorisation de Mise sur le Marché (AMM) ». L'AEM a répondu favorablement à cette demande et décidé de réévaluer le tétrazépam.

En attendant une éventuelle interdiction du produit, l'ANSM rappelle qu'il existe d'autres prises en charges possibles des contractures musculaires, notamment non-médicamenteuses.

En cas de nécessité d'utilisation du tétrazépam, il est important de « limiter sa durée d'utilisation au strict minimum ».

Le tétrazépam n'est plus remboursé par la Sécurité Sociale depuis décembre 2011.

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