Position de l'Europe sur les cox-2

EMEA announces COX-2 restrictions

Following discussions at a committee meeting, the European Medicines Agency has announced a number of regulatory actions for the COX-2 inhibitor class of medicines, including the introduction of several new safety restrictions.
18 Feb 2005, 16:32 GMT -
The Committee for Medicinal Products for Human Use (CHMP) concluded that the available data show an increased risk of cardiovascular adverse events for COX-2 inhibitors as a class. The data also suggest an association between duration and dose of intake and the probability of suffering a cardiovascular event, the committee found.
Urgent safety restrictions have now been taken for COX-2 inhibitors available in the European Union. These include the introduction of a contra-indication for all COX-2 inhibitors in patients with ischaemic heart disease or stroke, with a contra-indication for Merck & Co's Arcoxia in hypertension patients whose blood pressure is not under control added as a further measure.
A warning has been introduced for prescribers to exercise caution when prescribing COX-2 inhibitors for patients with risk factors for heart disease, such as hypertension, hyperlipidemia, diabetes and smoking, as well as for patients with peripheral arterial disease.Given the association between cardiovascular risk and exposure to COX-2 inhibitors, doctors are now advised to use the lowest effective dose for the shortest possible duration of treatment.
These CHMP curbs are interim measures pending the finalization of the class review, which is expected in April 2005.
The committee also concluded that more research is needed to evaluate the cardiovascular safety of COX-2 inhibitors, and that ongoing cardiovascular trials should continue as planned.

Source: Datamonitor Newswire
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