메뉴 건너뛰기




Volumn 25, Issue 6, 2009, Pages 1535-1550

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

Author keywords

Cyclooxygenase 2; Drug toxicity; Hemorrhage; Postmarketing; Product surveillance; Rofecoxib; Thrombosis

Indexed keywords

ACETYLSALICYLIC ACID; ALENDRONIC ACID; AMLODIPINE BESYLATE; ANTICOAGULANT AGENT; ATENOLOL; ATORVASTATIN; CELECOXIB; CLOPIDOGREL; CONJUGATED ESTROGEN; CYCLOOXYGENASE 1 INHIBITOR; CYCLOOXYGENASE 2 INHIBITOR; DICLOFENAC; DICLOFENAC POTASSIUM; DIGOXIN; ENALAPRIL; EXCEDRIN; FUROSEMIDE; HEPARIN; IBUPROFEN; INDOMETACIN; KETOPROFEN; KETOROLAC; KETOROLAC TROMETAMOL; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; MELOXICAM; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; OMEPRAZOLE; ORUVAIL UNK; PARACETAMOL; PIROXICAM; PREDNISONE; ROFECOXIB; SIMVASTATIN; SULINDAC; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALDECOXIB; VITAMIN; WARFARIN;

EID: 67649425383     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007990902953286     Document Type: Article
Times cited : (10)

References (33)
  • 1
    • 0032522873 scopus 로고    scopus 로고
    • Incidence of adverse drug reactions in hospitalized patients: A meta- Analysis of prospective studies
    • DOI 10.1001/jama.279.15.1200
    • Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-1205 (Pubitemid 28193431)
    • (1998) Journal of the American Medical Association , vol.279 , Issue.15 , pp. 1200-1205
    • Lazarou, J.1    Pomeranz, B.H.2    Corey, P.N.3
  • 2
    • 0033518849 scopus 로고    scopus 로고
    • Postmarketing surveillance and adverse drug reactions current perspectives and future needs
    • DOI 10.1001/jama.281.9.824
    • Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999;281(9):824-829 (Pubitemid 29113743)
    • (1999) Journal of the American Medical Association , vol.281 , Issue.9 , pp. 824-829
    • Brewer, T.1    Colditz, G.A.2
  • 4
    • 0033636535 scopus 로고    scopus 로고
    • Clinical and economic impact of adverse drug reactions in hospitalized patients
    • Suh DC, Woodall BS, Shin SK et al. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother 2000;34(12):1373-1379
    • (2000) Ann Pharmacother , vol.34 , Issue.12 , pp. 1373-1379
    • Suh, D.C.1    Woodall, B.S.2    Shin, S.K.3
  • 5
    • 51449124055 scopus 로고    scopus 로고
    • Cardiovascular and gastrointestinal toxicity of selective cyclo-oxygenase-2 inhibitors in man
    • Dajani EZ, Islam K. Cardiovascular and gastrointestinal toxicity of selective cyclo-oxygenase-2 inhibitors in man. J Physiol Pharmacol 2008;59(Suppl. 2):117-133
    • (2008) J Physiol Pharmacol , vol.59 , Issue.SUPPL. 2 , pp. 117-133
    • Dajani, E.Z.1    Islam, K.2
  • 7
    • 67649454049 scopus 로고    scopus 로고
    • Merck and Company IWS, NJ, USA
    • Merck and Company IWS, NJ, USA. Vioxx Product Insert, 2002.
    • (2002) Vioxx Product Insert
  • 8
    • 0035833502 scopus 로고    scopus 로고
    • The coxibs, selective inhibitors of cyclooxygenase-2
    • DOI 10.1056/NEJM200108093450607
    • FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001;345(6):433-442 (Pubitemid 32747607)
    • (2001) New England Journal of Medicine , vol.345 , Issue.6 , pp. 433-442
    • Fitzgerald, G.A.1    Patrono, C.2
  • 10
    • 0035189633 scopus 로고    scopus 로고
    • COX-2 inhibitors and cardiovascular risk: We defend our data and suggest caution
    • 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):963-964 (Pubitemid 33100712)
    • (2001) Cleveland Clinic Journal of Medicine , vol.68 , Issue.11 , pp. 963-964
    • Mukherjee, D.1    Nissen, S.E.2    Topol, E.J.3
  • 12
    • 31344470641 scopus 로고    scopus 로고
    • Expression of concern: Bombardier et al., 'Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis'
    • 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.
    • (2000) N Engl J Med , vol.343 , pp. 1520-1528
    • Curfman, G.D.1    Morrissey, S.2    Drazen, J.M.3
  • 13
    • 29544442045 scopus 로고    scopus 로고
    • N Engl J Med 2005;353(26):2813-2814
    • (2005) N Engl J Med , vol.353 , Issue.26 , pp. 2813-2814
  • 16
    • 16644379746 scopus 로고    scopus 로고
    • Merck withdraws Vioxx. FDA issues public health advisory
    • Merck withdraws Vioxx. FDA issues public health advisory. FDA Consum 2004;38(6):11.
    • (2004) FDA Consum , vol.38 , Issue.6 , pp. 11
  • 17
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions
    • 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):1363-1369
    • (2005) Arch Intern Med , vol.165 , Issue.12 , pp. 1363-1369
    • Wysowski, D.K.1    Swartz, L.2
  • 20
    • 33645815078 scopus 로고    scopus 로고
    • Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants
    • Mosholder AD, Pamer CA. Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants. J Child Adolesc Psychopharmacol 2006;16(1-2):33-36
    • (2006) J Child Adolesc Psychopharmacol , vol.16 , Issue.1-2 , pp. 33-36
    • Mosholder, A.D.1    Pamer, C.A.2
  • 21
    • 1842734427 scopus 로고    scopus 로고
    • Identification and evaluation of a possible signal of exacerbation of colitis during rofecoxib treatment, using Prescription-Event Monitoring data
    • DOI 10.1111/j.1365-2710.2004.00550.x
    • 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):171-181 (Pubitemid 38482483)
    • (2004) Journal of Clinical Pharmacy and Therapeutics , vol.29 , Issue.2 , pp. 171-181
    • Layton, D.1    Heeley, E.2    Shakir, S.A.W.3
  • 23
    • 0007430490 scopus 로고
    • Mathematical models in adverse drug reaction assessment
    • D'Arcy FF, Griffin JP (eds) Oxford: Oxford University Press
    • Weber J. Mathematical models in adverse drug reaction assessment. In: D'Arcy FF, Griffin JP (eds) Iatrogenic Diseases. Oxford: Oxford University Press, 1986:102-107
    • (1986) Iatrogenic Diseases , pp. 102-107
    • Weber, J.1
  • 24
    • 34447306023 scopus 로고    scopus 로고
    • Bleeding complications with warfarin use: A prevalent adverse effect resulting in regulatory action
    • DOI 10.1001/archinte.167.13.1414
    • 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):1414-1419 (Pubitemid 47052441)
    • (2007) Archives of Internal Medicine , vol.167 , Issue.13 , pp. 1414-1419
    • Wysowski, D.K.1    Nourjah, P.2    Swartz, L.3
  • 25
    • 34548602369 scopus 로고    scopus 로고
    • Serious adverse drug events reported to the Food and Drug Administration, 1998-2005
    • 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):1752-1759
    • (2007) Arch Intern Med , vol.167 , Issue.16 , pp. 1752-1759
    • Moore, T.J.1    Cohen, M.R.2    Furberg, C.D.3
  • 26
    • 33750944984 scopus 로고    scopus 로고
    • 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
    • DOI 10.1016/S0140-6736(06)69666-9, PII S0140673606696669
    • 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): 1771-1781 (Pubitemid 44739003)
    • (2006) Lancet , vol.368 , Issue.9549 , pp. 1771-1781
    • Cannon, C.P.1    Curtis, S.P.2    Fitzgerald, G.A.3    Krum, H.4    Kaur, A.5    Bolognese, J.A.6    Reicin, A.S.7    Bombardier, C.8    Weinblatt, M.E.9    Van Der Heijde, D.10    Erdmann, E.11    Laine, L.12
  • 27
    • 58549116775 scopus 로고    scopus 로고
    • Risk of myocardial infarction and death associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) among healthy individuals: A nationwide cohort study
    • 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):190-197
    • (2008) Clin Pharmacol Ther , vol.85 , Issue.2 , pp. 190-197
    • Fosbol, E.1    Gislason, G.2    Jacobsen, S.3
  • 28
    • 33747125484 scopus 로고    scopus 로고
    • Risk of death or reinfarction associated with the use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs after acute myocardial infarction
    • DOI 10.1161/CIRCULATIONAHA.106.616219, PII 0000301720060627000010
    • 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):2906-2913 (Pubitemid 44297231)
    • (2006) Circulation , vol.113 , Issue.25 , pp. 2906-2913
    • Gislason, G.H.1    Jacobsen, S.2    Rasmussen, J.N.3    Rasmussen, S.4    Buch, P.5    Friberg, J.6    Schramm, T.K.7    Abildstrom, S.Z.8    Kober, L.9    Madsen, M.10    Torp-Pedersen, C.11
  • 30
    • 33749339372 scopus 로고    scopus 로고
    • Cardiovascular risk and inhibition of cyclooxygenase: A systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2
    • DOI 10.1001/jama.296.13.jrv60011
    • 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):1633-1644 (Pubitemid 44511610)
    • (2006) Journal of the American Medical Association , vol.296 , Issue.13 , pp. 1633-1644
    • McGettigan, P.1    Henry, D.2
  • 31
    • 36348932768 scopus 로고    scopus 로고
    • COX-2 inhibitors and cardiovascular risk
    • DOI 10.1097/FJC.0b013e318157f72d, PII 0000534420071100000002
    • Funk CD, FitzGerald GA. COX-2 inhibitors and cardiovascular risk. J Cardiovasc Pharmacol 2007;50(5):470-479 (Pubitemid 350146448)
    • (2007) Journal of Cardiovascular Pharmacology , vol.50 , Issue.5 , pp. 470-479
    • Funk, C.D.1    Fitzgerald, G.A.2
  • 32
    • 67649455664 scopus 로고    scopus 로고
    • Merck and Company IWS, NJ, USA
    • Merck and Company IWS, NJ, USA. Celebrex® Product Insert, 2008.
    • (2008) Celebrex® Product Insert
  • 33
    • 2942577838 scopus 로고    scopus 로고
    • Do some inhibitors of COX-2 increase the risk of thromboembolic events?: Linking pharmacology with pharmacoepidemiology
    • 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): 427-456
    • (2004) Drug Saf , vol.27 , Issue.7 , pp. 427-456
    • Clark, D.W.1    Layton, D.2    Shakir, S.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.