EMEA recommends suspension of carisoprodol drugs

The European Medicines Agency (EMEA) has recommended the suspension of marketing authorizations for all medicinal products containing carisoprodol, which are available in 12 European Union member states under prescription, mainly for the treatment of acute lower back pain. Finalizing its review, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines are greater than their benefits, and recommended their suspension.

The review of carisoprodol-containing medicinal products was initiated in September 2007 following plans made for its withdrawal from the Norwegian market (scheduled to take effect as of May 2008), due to new information relating to an increased risk of abuse or addiction as well as intoxication and events related to psychomotor impairment. The CHMP reviewed the safety of these medicines to assess whether the regulatory actions taken by Norway should be implemented throughout the European Union.