The European Medicines Agency (EMEA) has recommended the withdrawal of the marketing authorisations for all lumiracoxib-containing medicines, because of the risk of serious side effects affecting the liver. Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group 'COX-2 inhibitors'. It is used for symptomatic relief in the treatment of osteoarthritis of the hip and knee.
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 The CHMP therefore recommended that the marketing authorisation for these medicines should be withdrawn in all European Union (EU) Member States where they are approved.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 The CHMP was asked to give a scientific opinion on whether the marketing authorisations for lumiracoxib should be withdrawn, suspended or changed across the EU.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.
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 The CHMP therefore recommended that the marketing authorisation for these medicines should be withdrawn in all European Union (EU) Member States where they are approved.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 The CHMP was asked to give a scientific opinion on whether the marketing authorisations for lumiracoxib should be withdrawn, suspended or changed across the EU.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.
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