To the Editor: I am concerned that several statements in the article on cyclooxygenase-2 (COX-2) inhibition by Cleland and colleagues1 do not accurately reflect the clinical data.
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Correspondence:
- 1. Cleland LG, James MJ, Stamp LK, Penglis PS. COX-2 inhibition and thrombotic tendency: a need for surveillance. Med J Aust 2001; 175: 214-217.
- 2. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284: 1247-1255.
- 3. Throckmorton DC. FDA Center for Drug Evaluation and Research memorandum. Comparative safety of celecoxib, diclofenac and ibuprofen. Rockville, MD: FDA, 1 May 2001. <http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_07.pdf>
- 4. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-1528.
- 5. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284: 1247-1255.
- 6. US Food and Drug Authority. NDA 20-998/S-009. Celebrex capsules (Celecoxib). Medical Officer Review. Sept 2001 <http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_03_med.pdf>
- 7. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284: 1247-1255.
- 8. FDA Advisory Committee Briefing Document, NDA 21-042, s007, VIOXX Gastrointestinal Safety <http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b2_03_med.pdf>
- 9. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients eith rheumatoid arthritis. N Engl J Med 2000; 343: 1520-1528.
- 10. Cleland LG, James MJ, Stamp LK, Penglis PS. COX-2 inhibition and thrombotic tendency: a need for surveillance. Med J Aust 2001; 175: 214-217.
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