European Medicines Agency announces regulatory action on COX-2 inhibitors

Following the worldwide withdrawal of Vioxx, the European Medicines Agency (EMEA) was asked by the European Commission, in October 2004, to conduct a review of COX-2 inhibitor medicines, with regard to cardiovascular safety. COX-2 inhibitor medicines available in Europe already contain stringent warnings and precautions on cardiovascular risks. The ongoing review of this class of medicines by the EMEA is looking at whether there is a need to make changes to the existing marketing authorisations throughout the European Union, for example, with regard to precautions and warnings, and whether additional studies are needed.

• Primary Source

European Medicines Agency: Questions and answers on Celecoxib/Cox-2 inbitors, 17.2.05 http://www.emea.europa.eu/htms/human/press/cox2QA.htm

European Medicines Agency: Public Statement: EMEA/62757/2005 (17.2.05) http://www.emea.europa.eu/pdfs/human/press/pr/6275705en.pdf

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