- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Meprobamate licence suspension recommended

The European Medicines Agency (EMA) has recommended (PDF) that the marketing authorisations for all meprobamate containing medicines are suspended over the next 15 months.

A recent review looked at all available data on the safety and efficacy of these medicines. It was concluded that there is a risk of serious and potentially fatal side effects even when taking this drug under normal conditions of use. The risks were even higher in cases of unintended overdose due to the narrow therapeutic window.

The EMA are advising doctors to stop prescribing meprobamate over the next 15 months and to consider using alternative treatments in line with national recommendations. Patients are to discuss their treatment at their next routine appointment.

Action: Clinicians should be aware of this recommendation. Meprobamate is not widely used but it may be prudent to search clinical systems to identify those patients affected by this recommendation.