Celebrex has been associated with an increased risk of serious adverse cardiovascular (CV) events in a long-term placebo controlled trial. Based on the currently available data, FDA has concluded that an increased risk of serious adverse CV events appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). FDA has requested that the package insert for all NSAIDs, including Celebrex, be revised to include a boxed warning to highlight the potential increased risk of CV events and the well described risk of serious, and potentially life-threatening, gastrointestinal bleeding. FDA has also requested that the package insert for all NSAIDs be revised to include a contraindication for use in patients immediately post-operative from coronary artery bypass (CABG) surgery.

For more information, visit http://www.fda.gov/cder/drug/infopage/celebrex/celebrex-ptsk.htm