Canada, USA. Changes to the labelling for celecoxib (Celebrex) have been announced in Canada and the US and are based on the results of the Celecoxib Long-term Arthritis Safety Study (CLASS). Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) approved for use in the acute and chronic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults. Health Canada is advising Canadians that, in the CLASS results:
• There were no differences in the risk of ulcer complications (gastrointestinal bleeding, perforation and obstruction) among the 3 groups of arthritis patients treated with celecoxib (Celebrex, 400 mg twice daily; 4-fold and 2-fold greater than the daily recommended OA and RA doses respectively), diclo-fenac and ibuprofen (75 mg twice daily and 800 mg thrice daily, respectively; common therapeutic doses for OA and RA).
• In the indicated doses, the risk of ulcer complications and symptomatic ulcers (ulcers with abdominal pain, dyspepsia, nausea or vomiting) was lower for celecocib (Celebrex) than for ibuprofen, but not different from diclofenac.
• The risk of ulcer complications in patients taking celecoxib (Celebrex) and low dose aspirin was four times that of patients taking celecoxib (Celebrex) alone.
The US FDA has advised that the following safety data from CLASS be included into the product label
• The overall safety of celecoxib used (400 mg twice a day) at twice the highest approved dose for rheumatoid arthritis was similar to commonly used doses of diclofenac and ibuprofen
• The high doses of celecoxib used (400 mg twice a day) were not associated with an increased rate of serious cardiovascular events compared with diclofenac and ibuprofen
• Patients receiving celecoxib had fewer clinically relevant reductions in haemoglobin compared with patients receiving diclofenac or ibuprofen
• Patients receiving both low-dose aspirin and celecoxib had a higher rate of gastrointestinal (GI) events than those receiving celecoxib alone.
The new labelling will also include information regarding the risk of serious GI and renal effects in elderly patients.
1. Gastrointestinal toxicity with celecoxib vs non-steroidal antiinflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomised controlled trial. Celecoxib long-term arthritis safety study. JAMA 284(10): 1247-55, 13 Sep 2000.
2. Health Canada Warnings/Advisories, 23 May 2002. Available from URL: http://www.hc-sc.gc.ca
3. FDA Talk Paper, 7 Jun 2002. Available from URL: http://www.fda.gov