Cox-2 Drug Class Gets Restrictions From EMEA

The European Medicines Agency (EMEA) has become the first regulatory body to impose sweeping restrictions on Cox-2 inhibitor drugs, announcing recently that it will require labeling changes and physician warnings for the controversial drug class.

The EMEA, the European Union's equivalent of the FDA, has been conducting a formal assessment of Cox-2 safety issues since Merck voluntarily recalled its pain medication Vioxx (rofecoxib) last fall. The EMEA's Committee for Medicinal Products for Human Use recently convened to discuss the outcome of the assessment and recommend possible regulatory actions. Following that meeting the agency issued several "urgent" safety restrictions on Cox-2s.

The EMEA said the restrictions are interim measures pending the finalization of its Cox-2 safety assessment, which is expected in April.

To view the EMEA's announcement, go to http://www.emea.eu.int/pdfs/human/press/pr/6275705en.pdf (http://www.emea.eu.int/pdfs/human/press/pr/6275705en.pdf).