USA. FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labelling changes to their products. The FDA has recommended label changes for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a cyclooxygenase-2 (COX-2) selective NSAID, have been asked to revise the labelling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The agency based its advice on a review of the regulatory histories and databases on the various NSAIDs.
Drug Information Page. United States Food and Drug Administration, 16 June 2005 (http://www.fda.gov).