The European Medicines Agency (EMEA) is recommending that marketing authorisations for all medications containing carisoprodol are suspended.
Carisoprodol is found in prescription drugs in 12 EU States and is mainly used for the treatment of acute lower back pain.
The EMEA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines are greater than their benefits.
The review of drugs containing carisoprodol was launched in September following new data relating to an increased risk of abuse or addiction, as well as intoxication and events related to psychomotor impairment.
In the light of these findings, the CHMP considered that the risks were too great and moved to call for the marketing authorisations be suspended.
But due to the possibility of withdrawal symptoms, patients should not stop taking carisoprodol before seeking advice from their doctor on other options for treatment.
Any switch to new medication should be made gradually and under medical supervision, it added.
The CHMP’s opinion will now be sent to the European Commission for the adoption of a decision, which will be binding across all EU countries.
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