The European Medicines Agency has concluded its review of the COX-2 inhibitor class of drugs and has recommended the continued suspension of Pfizer’s Bextra (valdecoxib) in addition to new contraindications and warnings for the COX-2s that are still available on the continent.
Bextra was originally pulled from both the European and US markets in April after regulators ruled that the safety risks associated with its use – namely the cardiovascular risks, which were coupled with the additional risks of serious and potentially fatal skin reactions – outweigh its benefits [[08/04/05a]]. The EMEA says that it will review the Bextra suspension again in one year’s time, giving Pfizer the opportunity to provide further safety information and other relevant data.
The agency also said that available data showed that the other COX-2 inhibitors – Pfizer’s Celebrex (celecoxib) and Dynastat (parecoxib), Merck & Co’s Arcoxia (etoricoxib), Novartis’ Prexige (lumiracoxib) – show an increased risk of thrombotic adverse cardiovascular reactions, such as heart attacks and strokes. It has ruled that the drugs must not be used in patients with established ischaemic heart disease and/or stroke, and also in patients with peripheral arterial disease – confirming the agency’s February findings [[18/02/05a]]. In addition, the lowest effective dose should be prescribed, for the shortest possible time.
