The European Medicines Agency (EMEA) received summary data on 21 December 2004 from 2 clinical trials (APC and PreSAP trials) relating to celecoxib and is actively reviewing these and other data. A preliminary assessment of the summary data, while not conclusive, indicates that an increased risk of serious cardiovascular events seen in the APC trial may be related to the dose and duration of treatment.

The EMEA has now decided to accelerate its review of COX-2 inhibitors, requesting all marketing authorisation holders to submit all new data and analysis early in January 2005 and present them at the 17-20 January 2005 meeting of the EMEA's Committee on Medicinal Products for Human Use (CHMP).

The Agency will issue any further update at the end of that meeting. 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 (e.g. precautions, warnings, etc) and whether additional studies are needed. The choice of treatment with COX-2, other analgesic or anti-inflammatory medicines should be made on the basis of individual patient characteristics.

In addition to the EMEA advice published on 22 October 2004 and pending the outcome of the Agency's review, the national authorities in the Member States have made recommendations for the use of COX-2 inhibitors, including celecoxib (Celebrex, Celebra, etc), to patients and healthcare professionals.

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