The Pharmaceutical Journal
Vol 273 No 7321 p553
16 October 2004

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EMEA to review COX-2 heart data again

Following the worldwide withdrawal of rofecoxib (Vioxx and Vioxx Acute) earlier this month (PJ, 9 October, p505), the European Medicines Evaluation Agency has decided to review the cardiovascular safety of all licensed cyclo-oxygenase-2 selective inhibitors.

It says it will examine available long-term data on cardiovascular safety for celecoxib (Celebrex), etoricoxib (Arcoxia), parecoxib (Dynastat), rofecoxib and valdecoxib (Bextra) by the end of October. The EMEA has previously reviewed this class of drug and concluded, in November 2003, that the overall benefits of COX-2 inhibitors outweighed the risk of side effects for the target patient population.

However, at that time, the EMEA did recommend that the drugs should be used with caution in patients with a known history of heart disease.