European Medicines Agency Recommends Suspension Of Marketing Authorisations For Carisoprodol-Containing Medicinal Products

The European Medicines Agency (EMEA) has recommended the suspension of
marketing authorisations for all medicinal products containing
carisoprodol. Carisoprodol products are available in 12 Member States
under prescription, mainly for the treatment of acute lower back pain.


Finalising 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 the suspension of marketing
authorisations in those Member States where the product is approved.


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 EU
countries.


Following the assessment of the available information on the safety of
carisoprodol-containing medicinal products, the CHMP concluded that
there is evidence for carisoprodol-associated risk of abuse and
addiction, intoxication and psychomotor impairment. In the light of
these findings the CHMP considered that the risks of these medicines
outweigh their benefits. The CHMP therefore recommended the suspension
of the marketing authorisations of all carisoprodol-containing medicinal
products.


Due to the risk of withdrawal symptoms, patients should not stop
carisoprodol treatment before seeking advice from their doctor on other
therapeutic options. Any switch to new medication should be made
gradually and under medical supervision.


The CHMP opinion will now be sent to the European Commission for the
adoption of a decision, applicable in all EU countries.


Notes:


1. More information about the review is available in a separate
question-and-answer-document:
click here.


2. Carisoprodol-containing medicinal products are available in Europe in
the Czech Republic, Denmark, Finland, Greece, Hungary, Iceland, Italy,
Norway, the Slovak Republic, Spain, Sweden and the United Kingdom.


3. Carisoprodol-containing medicinal products include Somadril, Somadril
comp, Carisoma, Soma Complex, Scutamil C, Relacton-C, Mio Relax and
Relaxibys.


4. The review of carisoprodol was conducted under Article 107 of the
Community code relating to medicinal products for human use (Directive
2001/83/EC). This type of procedure is initiated in cases where a Member
State withdraws, suspends or changes the marketing authorisation of a
nationally authorised medicine as a result of the evaluation of safety
data. It provides for a harmonised European approach because the CHMP is
asked to prepare an opinion on whether or not the regulatory actions
should be implemented throughout the European Union.


5. This press release, together with other information on the work of
the EMEA, can be found on the EMEA website: emea.europa.eu