The European authorities are suspending the sale of tetrazepam-based drugs in all EU member states. Myolastan muscle relaxer will no longer be sold as of July.
From July 8, 2013 you will no longer find Myolastan in your pharmacies. This well-known muscle relaxer will disappear from the market from that date. The Medicines Safety Agency (Ansm), in agreement with the European authorities, informs this Tuesday, July 2 of the suspension, in all member states of the European Union, of the marketing authorizations (Amm) of medicinal products to tetrazepam base, a substance indicated in the treatment of painful contractures in rheumatology. This announcement is the logical continuation of previous decisions made by European and French health authorities.
In fact, at the beginning of April 2013, the European Medicines Agency (Ema) concluded that the tetrazepam molecule was associated with “risks of rare but very serious and sometimes fatal skin reactions compared to other benzodiazepines”. She also believed that in light of these risks, the available data on the efficacy of this proprietary medicinal product were “not strong enough” to support its use. This is why Ema already recommended at that date the suspension of treatment with tetrazepam. In reaction, the Ansm told French doctors to no longer prescribe the muscle relaxant Myolastan.
And, in June 2013, the European Commission approved and adopted this suspension of Amm tetrazepam throughout the European Union due to a benefit / risk balance now unfavorable for these specialties. As a result, Myolastan and its generics will disappear from pharmacies in less than a week.
As a reminder, a French pharmacovigilance survey had highlighted “a high frequency of skin side effects such as Lyell and Stevens-Johnson syndromes (which result in sudden destruction of the surface layer of the skin and mucous membranes). ) and drug hypersensitivity syndromes (Dress) ”after taking tetrazepam treatments. The Ansm had also reported other serious effects (neurological and psychiatric).
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