Finalising a review of available information on the safety of lumiracoxib, which concentrated on worldwide data on liver side effects, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded at its December 2007 meeting that the risks of lumiracoxib-containing medicines are greater than their benefits. The CHMP therefore recommended that the marketing authorisation for these medicines should be withdrawn in all European Union (EU) Member States where they are approved.
The Europe-wide review was started on 15 November 2007 following assessment of reports of serious liver injury by the United Kingdom. The CHMP was asked to give a scientific opinion on whether the marketing authorisations for lumiracoxib should be revoked (withdrawn), suspended or changed across the EU. On 19 November 2007 the United Kingdom suspended the marketing authorisation of this medicine. Similar regulatory action was taken in Germany, Cyprus and Belgium.
The liver safety of lumiracoxib has been monitored continuously since its launch in 2005. In August 2007, the product information was updated with contraindications for patients with potential liver problems and advice to doctors that they should frequently monitor patients treated with lumiracoxib for liver reactions. More spontaneous reports of serious liver problems have been received since then, which have increased the concerns regarding hepatic safety for lumiracoxib. In addition, the CHMP considered that the proposed measures to reduce the risk for liver reactions can not assure adequate patient safety, and are not considered realistic given the approved clinical indication.
Consequently, the CHMP is now recommending the withdrawal of the marketing authorisations.
Patients taking lumiracoxib-containing medicines should contact their doctor as they may need to change to other medicines if there is a need for treatment.
The CHMP's opinion will now be forwarded to the European Commission for the adoption of a decision.
For further information, visit www.emea.europa.eu.