Germany is planning to restrict the use of the COX-2 inhibitor class of painkillers in the wake of investigations from regulators on both sides of the Atlantic into the products' cardiac safety [[18/02/05a]], [[21/02/05a]], the Federal Institute for Drugs and Medical Devices said yesterday.
The regulator is planning to issue a ruling in the next few days, which will prevent the products from being used in patients who have suffered a heart attack or stroke, have circulatory disorders or are at an increased risk of developing these conditions. It is also recommending that COX-2s – including Pfizer’s Celebrex (celecoxib) and Bextra (valdecoxib) – should be used at the lowest possible dose and only for as long as is absolutely necessary. It singled out Merck & Co’s new entry into the COX-2 fray, Arcoxia (etoricoxib), saying it should no longer be used in patients with high blood pressure that cannot be stabilised.
Last week, the European advisory board, the CHMP, revealed a number of “urgent safety restrictions” for the drugs [[18/02/05a]]. The agency is continuing to assess the products’ risk profile and is expected to issue a definitive report in April.