All marketing authorisations for meprobamate-containing medicines for oral use in the European Union should be suspended, according to the European Medicines Agency. The reason behind is that their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits. EMA also recommends a gradual withdrawal period of 15 months.

The European Medicines Agency has recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union. The European Agency considers that their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits. Doctors should stop prescribing meprobamate-containing medicines over the next 15 months and consider alternative treatments in line with national recommendations for the condition being treated. The European Medicines Agency released recently the adverse reaction reports related to Septrin following a European Ombudsman recommendation.

Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps, and insomnia. Patients currently taking the medicines should discuss their treatment with their doctor at their next routine appointment.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed all available data on the safety and efficacy of these medicines and noted that there was a risk of serious and potentially fatal side effects, such as coma, in patients taking meprobamate-containing medicines under normal conditions of use. The CHMP also noted that some patients can become addicted to the medicine, leading to serious and sometimes fatal side effects if they stop treatment abruptly after using it for a long time.