The European Medicines Agency (EMA) has recommended the suspension of all marketing authorisations for oral medicines containing meprobamate, a sedative used to treat symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps, and insomnia. The decision was taken because the risks of these medicines, particularly of serious CNS adverse effects, are greater than their benefits.

To ensure prescribers have enough time to determine the most appropriate treatments for patients, the withdrawal from the market will be carried out gradually, within 15 months of the decision. Doctors should consider alternative treatments in line with national recommendations for the condition being treated. 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) 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. These risks were increased due to the danger of unintentional overdose because of the narrow therapeutic window. It was also noted that some patients can become addicted to the medicine, leading to serious and sometimes fatal side effects if treatment is stopped abruptly.