One of the muscle relaxants – and classified at the same time as an anxiolytic – more used and popular in Western societies, the Myolastan, is under suspicion. At least in France. This country has requested an investigation from the European Medicines Agency (EMA), after having detected in its country during the last 40 years some 1,600 adverse effects and eleven deaths. However, in Spain, the Ministry of Health has already communicated that it will not withdraw this medicine from Spanish pharmacies.
According to the Ministry, measures such as the one adopted by France are “very common” and it does not mean that this medicine is no longer safe.
Thus, Ministry sources indicate that “millions of people” consume drugs with tetrazepam, whose best-known trade name is Myolastan, from Sanofi Aventis, under the consideration that “the benefits of this treatment outweigh some adverse effects that, in addition, are known and listed in the prospectus”.
Health has explained that the EMA Safety Committee has initiated this inquiry in January at the request of the French Agency, in what is known as an “arbitration” procedure to “review the risk benefit ratio” of this drug.
The European Medicines Agency (EMA) confirmed today that it has launched an investigation into the muscle relaxant Myolastan at the request of France, where “serious skin reactions” have been detected.
The London-based community agency explained in a statement that investigate all side effects of tetrazepam-containing drugs. This is part of the family of benzodiazepines, which acts on the central nervous system and is especially indicated for patients with rheumatic problems. The investigation carried out by France ensures that Tetrazepam skin side effects are higher than those produced by other benzodiazepines.
THE EMA pointed out that the alarms went off after detecting cases of Stevens Johnson syndrome, toxic epidermal necrosis and other severe skin reactions. Medicines containing tetrazepam are marketed under different names in thirteen European Union (EU) countries, including Spain, and sold by prescription only.