Europe. The European Committee for Proprietary Medicinal Products (CPMP) has finalised a EU-wide review of the cyclooxygenase-2 (COX-2) inhibitor substances celecoxib, etoricoxib, parecoxib, rofecoxib and valdecoxib. The review was initiated by France in July 2002 due to gastrointestinal and cardiovascular safety concerns. The CPMP has concluded that the benefit-risk balance for these drugs remains positive for the target populations. However, the Committee recommends that the product label should be strengthened with additional warnings, in particular recommending caution in patients with underlying gastrointestinal and cardiovascular risks. The Committee also recommends adding (or modifying) warnings concerning the risk of severe skin and hypersensitivity reactions.

Reference:
EMEA Press Release EMEA/CPMP/5732/03/Final, 20 November 2003. Available from URL: http://www.emea.eu.int