Bextra, COX-2 Inhibitors, and NSAIDS: Public Health Advisory

The Food and Drug Administration (FDA) has asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. FDA is also asking manufacturers of all marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (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, potential life-threatening gastrointestinal (GI) bleeding associated with their use. Manufacturers of non-prescription (over-the-counter) NSAIDs are also being asked to revise their labeling to provide more specific information about the potential CV and GI risks of their individual products and remind patients that these products of the limited dose and duration of treatment in accordance with the package instructions.