The European Medicines Agency has recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union, because their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits.
The Committee has recommended that the withdrawal of the medicines from the market be carried out gradually, within 15 months of the European Commission decision.
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.
The review of meprobamate-containing medicines was started because the French authorities announced in July 2011 their intention to suspend the marketing authorisations for oral meprobamate-containing medicines because of serious side effects seen with these medicines.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed all available data on the safety and efficacy of these medicines, including data from studies, post-marketing surveillance and the published literature, as well as from poison control centres on cases of poisoning with meprobamate.
The 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.
The Committee considered that these risks were increased due to the danger of unintentional overdose because of the small difference between the treating dose and the dose that can harm patients, including elderly people.
The CHMP also noted that patients could become addicted to the medicine, leading to serious and sometimes fatal side effects if they stopped treatment abruptly after using it for a long time.
The Committee concluded that the benefits of meprobamate-containing medicines for oral use do not outweigh their risks