Celebrex Newsroom

FDA Recently Issued a Public Health Advisory About the Use of NSAIDS, Including COX-2 Selective Agents Such as Celebrex and Bextra.

Recently released data from controlled clinical trials suggests that these COX-2 selective agents may be associated with an increased risk of serious cardiovascular events. In these studies, the increased risk was associated with long term use of the drugs, or use in very high risk settings--immediately after heart surgery, for example. The results of these studies are preliminary, and they conflict with other data from studies of the same drugs.

Still, FDA is making some interim recommendations at this time. FDA is advising prescribers of Celebrex or Bextra to consider this emerging information when they're weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents. Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should also be taken into account for each prescribing situation.

FDA is analyzing the most recent studies of both COX-2 selective and nonselective NSAIDs to determine whether additional regulatory action is needed.

Additional Information:

FDA recently issued a public health advisory about the use of NSAIDS, including COX-2 selective agents such as Celebrex and Bextra
http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html

FDA Public Health Advisory - Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)
www.fda.gov/cder/drug/advisory/nsaids.htm

Safe Use of Over-the-Counter Pain Relievers (analgesics) and Fever Reducers (antipyretics)
http://www.fda.gov/cder/drug/analgesics/default.htm