Postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999–2002

References

• Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-5.
   PubMed Web of Science ®Google Scholar
• Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999;281(9):824-9.
   PubMed Web of Science ®Google Scholar
• O’Connell KA, Wood JJ, Wise RP et al. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006;295(3):293-8.
   PubMed Web of Science ®Google Scholar
• Suh DC, Woodall BS, Shin SK et al. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother 2000;34(12):1373-9.
   PubMed Web of Science ®Google Scholar
• Dajani EZ, Islam K. Cardiovascular and gastrointestinal toxicity of selective cyclo-oxygenase-2 inhibitors in man. J Physiol Pharmacol 2008;59(Suppl. 2):117-33.
   PubMedGoogle Scholar
• Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000;343(21):1520-8.
   PubMed Web of Science ®Google Scholar
• Merck and Company IWS, NJ, USA. Vioxx Product Insert, 2002.
   Google Scholar
• FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001;345(6):433-42.
   PubMed Web of Science ®Google Scholar
• Konstam MA, Weir MR, Reicin A et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2001;104(19):2280-8.
   PubMed Web of Science ®Google Scholar
• Mukherjee D, Nissen SE, Topol EJ. Cox-2 inhibitors and cardiovascular risk: we defend our data and suggest caution. Cleve Clin J Med 2001;68(11):963-4.
   PubMed Web of Science ®Google Scholar
• Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001;286(8):954-9.
   PubMed Web of Science ®Google Scholar
• Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., ‘Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis,’ N Engl J Med 2000;343:1520-8. N Engl J Med 2005;353(26):2813-14.
   PubMed Web of Science ®Google Scholar
• FitzGerald GA, Cheng Y, Austin S. COX-2 inhibitors and the cardiovascular system. Clin Exp Rheumatol 2001;19(6 Suppl. 25):S31-6.
   PubMed Web of Science ®Google Scholar
• Bresalier RS, Sandler RS, Quan H et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352(11):1092-102.
   PubMed Web of Science ®Google Scholar
• Merck withdraws Vioxx. FDA issues public health advisory. FDA Consum 2004;38(6):11.
   PubMedGoogle Scholar
• Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969–2002: the importance of reporting suspected reactions. Arch Intern Med 2005;165(12):1363-9.
   PubMed Web of Science ®Google Scholar
• Collaborative overview of randomised trials of antiplatelet therapy – I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. BMJ 1994;308(6921):81-106.
   Google Scholar
• Kerr DJ, Dunn JA, Langman MJ et al. Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer. N Engl J Med 2007;357(4):360-9.
   PubMed Web of Science ®Google Scholar
• Mosholder AD, Pamer CA. Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants. J Child Adolesc Psychopharmacol 2006;16(1-2):33-6.
   PubMed Web of Science ®Google Scholar
• Layton D, Heeley E, Shakir SA. Identification and evaluation of a possible signal of exacerbation of colitis during rofecoxib treatment, using Prescription-Event Monitoring data. J Clin Pharm Ther 2004;29(2):171-81.
   PubMed Web of Science ®Google Scholar
• Schwartz JI, Bugianesi KJ, Ebel DL et al. The effect of rofecoxib on the pharmacodynamics and pharmacokinetics of warfarin. Clin Pharmacol Ther 2000;68(6):626-36.
   PubMed Web of Science ®Google Scholar
• Weber J. Mathematical models in adverse drug reaction assessment. In: D’Arcy FF, Griffin JP (eds) Iatrogenic Diseases. Oxford: Oxford University Press, 1986:102-7.
   Google Scholar
• Wysowski DK, Nourjah P, Swartz L. Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch Intern Med 2007;167(13):1414-19.
   PubMed Web of Science ®Google Scholar
• Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998–2005. Arch Intern Med 2007;167(16):1752-9.
   PubMed Web of Science ®Google Scholar
• Cannon CP, Curtis SP, FitzGerald GA et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368(9549):1771-81.
   PubMed Web of Science ®Google Scholar
• Fosbol E, Gislason G, Jacobsen S et al. Risk of myocardial infarction and death associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) among healthy individuals: a nationwide cohort study. Clin Pharmacol Ther 2008;85(2):190-7.
   PubMed Web of Science ®Google Scholar
• Gislason GH, Jacobsen S, Rasmussen JN et al. Risk of death or reinfarction associated with the use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs after acute myocardial infarction. Circulation 2006;113(25):2906-13.
   PubMed Web of Science ®Google Scholar
• Kimmel SE, Berlin JA, Reilly M et al. Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 2005;142(3):157-64.
   PubMed Web of Science ®Google Scholar
• McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006;296(13):1633-44.
   PubMed Web of Science ®Google Scholar
• Funk CD, FitzGerald GA. COX-2 inhibitors and cardiovascular risk. J Cardiovasc Pharmacol 2007;50(5):470-9.
   PubMed Web of Science ®Google Scholar
• Merck and Company IWS, NJ, USA. Celebrex® Product Insert, 2008.
   Google Scholar
• Clark DW, Layton D, Shakir SA. Do some inhibitors of COX-2 increase the risk of thromboembolic events?: Linking pharmacology with pharmacoepidemiology. Drug Saf 2004;27(7):427-56.
   PubMed Web of Science ®Google Scholar