On November 16, 2007, the European Medicine Agency (EMEA), the European's equivalent to the Saudi Food and Drug Authority (SFDA), has recommended the suspension of marketing authorisations for all medicinal products containing carisoprodol. This product is marketed in Saudi Arabia as Somadril. Carisoprodol is mainly used for the treatment of acute (Short-Lived) lower back pain.

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 Committee for Human Medicinal Products (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.

Action that Healthcare Professional and patients should follow:

• Patients who are currently taking carisoprodol (Somadril) should consult their doctor or pharmacist to discuss which other treatment they can use.
• Prescribers should not issue any new prescriptions for carisoprodol and should switch patients currently taking the medicine to an alternative treatment if necessary.
• Any switch to new medication should be made gradually and under medical supervision.
• Patients should not stop taking carisoprodol abruptly, but should seek advice from their doctor on other treatment options
• Patients who have any questions should speak to their doctor or pharmacist.

Report Adverse Drug Reactions to the Saudi FDA:

Public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the Internet at: http://www.sfda.gov.sa/En/Drug/Topics/Pharmacovigilance_Center.htm