Meprobamate: licence to be cancelled
- Medicines and Healthcare products Regulatory Agency
- 18 April 2016
- Therapeutic area:
- Neurology, Pain management and palliation, Psychiatry, and Rheumatology
Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016.
Advice for healthcare professionals:
- Prescribers should review the treatment of any patient who is currently receiving a meprobamate-containing medicine with a view to switching them to an alternative treatment
- Prescribers should not start any new patients on medicines that contain meprobamate
Meprobamate is a carbamate used for short-term treatment of anxiety states or musculoskeletal disorders where, in either case, there is muscle tension or painful muscle spasm.
In 2012, the European Medicines Agency recommended withdrawal of meprobromate-containing medicines from the market following a review of their safety and effectiveness. The review concluded that the benefits of meprobamate do not outweigh its risks (which include dependence, withdrawal reactions, and abuse: see the Drug Safety Update article from February 2008).
Withdrawal of licence
No new stock will be released into the normal distribution chain after 31 December 2016, although existing stock placed on the market (and therefore already in the supply chain) before that date is likely to be dispensed until the products approach their expiry date.
Since 2012, prescribing of meprobamate in the UK has decreased; however, a small number of patients continue to receive it. These patients should be reviewed and where possible switched to an alternative safer treatment.
As with any unlicensed medicine there is a provision for the supply of unlicensed meprobamate, on the responsibility of the prescriber, who can judge the risks and benefits in consultation with the patient. However, the continued supply of a particular unlicensed medicine cannot be guaranteed.
Article citation: Drug Safety Update vol 9 issue 9, April 2016: 8.
Published: 18 April 2016