The hepatic safety and tolerability of the cyclooxygenase-2 selective NSAID celecoxib: pooled analysis of 41 randomized controlled trials

References

• Celebrex [prescribing information] revised January 2008. New York, NY: GD Searle LLC, a Division of Pfizer Inc. Available at: www.celebrex.com [Last accessed 18 December 2008].
   Google Scholar
• Traversa G, Bianchi C, Da Cas R, et al. Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. BMJ 2003;327:18-22
   PubMed Web of Science ®Google Scholar
• Rubenstein JH, Laine L. Systematic review: the hepatotoxicity of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2004;20:373-80
   PubMed Web of Science ®Google Scholar
• Tolman KG. Hepatotoxicity of non-narcotic analgesics. Am J Med 1998;105:13S-19S
   PubMedGoogle Scholar
• Rabkin JM, Smith MJ, Orloff SL, et al. Fatal fulminant hepatitis associated with bromfenac use. Ann Pharmacother 1999;33:945-7
   PubMed Web of Science ®Google Scholar
• Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience. Pharmacoepidemiol Drug Saf 2006;15:213-20
   PubMed Web of Science ®Google Scholar
• Walker AM. Quantitative studies of the risk of serious hepatic injury in persons using nonsteroidal antiinflammatory drugs. Arthritis Rheum 1997;40:201-8
   PubMed Web of Science ®Google Scholar
• Bjorkman D. Nonsteroidal anti-inflammatory drug-associated toxicity of the liver, lower gastrointestinal tract, and esophagus. Am J Med 1998;105:17S-21S
   PubMedGoogle Scholar
• Garcia Rodriguez LA, Williams R, Derby LE, et al. Acute liver injury associated with nonsteroidal anti-inflammatory drugs and the role of risk factors. Arch Intern Med 1994;154:311-16
   PubMed Web of Science ®Google Scholar
• Victorino RM, Silveira JC, Baptista A, et al. Jaundice associated with naproxen. Postgrad Med J 1980;56:368-70
   PubMed Web of Science ®Google Scholar
• Riley III TR, Smith JP. Ibuprofen-induced hepatotoxicity in patients with chronic hepatitis C: a case series. Am J Gastroenterol 1998;93:1563-5
   PubMed Web of Science ®Google Scholar
• O'Connor N, Dargan PI, Jones AL. Hepatocellular damage from non-steroidal anti-inflammatory drugs. QJM 2003;96:787-91
   PubMed Web of Science ®Google Scholar
• Zimmerman HJ. Update of hepatotoxicity due to classes of drugs in common clinical use: non-steroidal drugs, anti-inflammatory drugs, antibiotics, antihypertensives, and cardiac and psychotropic drugs. Semin Liver Dis 1990;10:322-33
   PubMed Web of Science ®Google Scholar
• Rabinovitz M, Van Thiel DH. Hepatotoxicity of nonsteroidal anti-inflammatory drugs. Am J Gastroenterol 1992;87:1696-704
   PubMed Web of Science ®Google Scholar
• Aithal GP, Day CP. Nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Clin Liver Dis 2007;11:563-vii
   PubMedGoogle Scholar
• Nachimuthu S, Volfinzon L, Gopal L. Acute hepatocellular and cholestatic injury in a patient taking celecoxib. Postgrad Med J 2001;77:548-50
   PubMed Web of Science ®Google Scholar
• Alegria P, Lebre L, Chagas C. Celecoxib-induced cholestatic hepatotoxicity in a patient with cirrhosis. Ann Intern Med 2002;137:75
   PubMed Web of Science ®Google Scholar
• Sanchez-Matienzo D, Arana A, Castellsague J, et al. Hepatic disorders in patients treated with COX-2 selective inhibitors or nonselective NSAIDs: a case/noncase analysis of spontaneous reports. Clin Ther 2006;28:1123-32
   PubMed Web of Science ®Google Scholar
• Yan B, Leung Y, Urbanski SJ, et al. Rofecoxib-induced hepatotoxicity: a forgotten complication of the coxibs. Can J Gastroenterol 2006;20:351-5
   PubMed Web of Science ®Google Scholar
• Merlani G, Fox M, Oehen HP, et al. Fatal hepatoxicity secondary to nimesulide. Eur J Clin Pharmacol 2001;57:321-6
   PubMed Web of Science ®Google Scholar
• Huster D, Schubert C, Berr F, et al. Rofecoxib-induced cholestatic hepatitis: treatment with molecular adsorbent recycling system (MARS). J Hepatol 2002;37:413-14
   PubMed Web of Science ®Google Scholar
• Tabibian JH, Tabibian N, Kaufman DM. Late-onset celecoxib-induced combined hepato-nephrotoxicity. Br J Clin Pharmacol 2008;66:150-1
   PubMed Web of Science ®Google Scholar
• Maddrey WC, Maurath CJ, Verburg KM, et al. The hepatic safety and tolerability of the novel cyclooxygenase-2 inhibitor celecoxib. Am J Ther 2000;7:153-8
   PubMedGoogle Scholar
• European Medicines Agency. Questions and answers on the recommendation to withdraw the marketing authorisations for lumiracoxib-containing medicines. December 2007. European Medicines Agency website. Available at: www.emea.europa.eu/pdfs/human/press/pr/QA_Lumiracoxib_53636307en.pdf [Last accessed 18 December 2008].
   Google Scholar
• Medicines and Healthcare Products Regulatory Agency. New contraindications and monitoring advice for lumiracoxib (Prexige) following notification of serious hepatotoxicity. August 2007. MHRA website. Available at: www.mhra.gov.uk/home/groups/plp/documents/websiteresources/con2032270.pdf [Last accessed 30 April 2008].
   Google Scholar
• US Food and Drug Administration. Advisory committee briefing document: Celecoxib and Valdecoxib Cardiovascular Safety. February 2005. US Food and Drug Administration website. Available at: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_03_Pfizer-Celerex-Bextra.pdf [Last accessed 15 December 2008].
   Google Scholar
• Zimmerman HJ. Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver, 2 nd edn. Philadelphia, PA: Lippincott Williams & Wilkins, 1999
   Google Scholar
• Rostom A, Goldkind L, Laine L. Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol 2005;3:489-98
   PubMed Web of Science ®Google Scholar
• 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. JAMA 2000;284:1247-55
   PubMed Web of Science ®Google Scholar
• Arber N, Eagle CJ, Spicak J, et al. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 2006;355:885-95
   PubMed Web of Science ®Google Scholar
• Bertagnolli MM, Eagle CJ, Zauber AG, et al. Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 2006;355:873-84
   PubMed Web of Science ®Google Scholar
• Banks AT, Zimmerman HJ, Ishak KG, et al. Diclofenac-associated hepatotoxicity: analysis of 180 cases reported to the Food and Drug Administration as adverse reactions. Hepatology 1995;22:820-7
   PubMed Web of Science ®Google Scholar
• Aithal GP. Diclofenac-induced liver injury: a paradigm of idiosyncratic drug toxicity. Expert Opin Drug Saf 2004;3:519-23
   PubMedGoogle Scholar
• Li Y, Slatter JG, Zhang Z, et al. In vitro metabolic activation of lumiracoxib in rat and human liver preparations. Drug Metab Dispos 2008;36:469-73
   PubMed Web of Science ®Google Scholar