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Volumn 38, Issue 8, 2012, Pages 905-907

Underreporting of hemorrhagic and thrombotic complications of pharmaceuticals to the US. Food and drug administration: Empirical findings for warfarin, clopidogrel, ticlopidine, and thalidomide from the southern network on adverse reactions (SONAR)

Author keywords

adverse drug events; clopidogrel; hemorrhage; thalidomide; ticlopidine; U.S. Food and Drug Administration; venous thromboembolism; warfarin

Indexed keywords

CLOPIDOGREL; THALIDOMIDE; TICLOPIDINE; WARFARIN;

EID: 84868554176     PISSN: 00946176     EISSN: 10989064     Source Type: Journal    
DOI: 10.1055/s-0032-1328890     Document Type: Article
Times cited : (31)

References (14)
  • 1
    • 84889452671 scopus 로고    scopus 로고
    • Strom B.L. ed. Pharmacoepidemiology. 4th ed Chichester, United Kingdom John Wiley & Sons, LTD
    • Ahmad S. R., Goetsch R. A., Marks N. M. Spontaneous reporting in the United States. In: Strom B. L., ed. Pharmacoepidemiology. 4th ed. Chichester, United Kingdom John Wiley & Sons, LTD: 2005; 135 159
    • (2005) Spontaneous Reporting in the United States , pp. 135-159
    • Ahmad, S.R.1    Goetsch, R.A.2    Marks, N.M.3
  • 2
    • 84879995485 scopus 로고    scopus 로고
    • Title 21 314.80 Postmarketing reporting of adverse drug experiences
    • Accessed May 3, 2012
    • Title 21 314.80 Postmarketing reporting of adverse drug experiences. United States Code of Federal Regulations. 2011. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80. Accessed May 3, 2012
    • (2011) United States Code of Federal Regulations
  • 3
    • 84879995421 scopus 로고    scopus 로고
    • Signals for two newly approved drugs and 2010 annual summary
    • Accessed May 3, 2012
    • Moore T. J., Cohen M. R., Furberg C. D. Signals for two newly approved drugs and 2010 annual summary. QuarterWatch: monitoring MedWatch reports. 2012. Available at: http://www.ismp.org/QuarterWatch/pdfs/2010Q4.pdf. Accessed May 3, 2012
    • (2012) QuarterWatch: Monitoring MedWatch Reports
    • Moore, T.J.1    Cohen, M.R.2    Furberg, C.D.3
  • 4
    • 84861131508 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Accessed May 3, 2012
    • U.S. Food and Drug Administration. Reports Received and Reports Entered into AERS By Year. 2011. Available at: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm070434.htm. Accessed May 3, 2012
    • (2011) Reports Received and Reports Entered into AERS by Year
  • 5
    • 0027252647 scopus 로고
    • Introducing MEDWatch: A new approach to reporting medication and device adverse effects and product problems
    • DOI 10.1001/jama.269.21.2765
    • Kessler D. A. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA: 1993; 269 21 2765 2768 (Pubitemid 23154251)
    • (1993) Journal of the American Medical Association , vol.269 , Issue.21 , pp. 2765-2768
    • Kessler, D.A.1
  • 6
    • 84942481880 scopus 로고
    • Hospitalizations with adverse events caused by digitalis therapy among elderly Medicare beneficiaries
    • DOI 10.1001/archinte.154.13.1482
    • Warren J. L., McBean A. M., Hass S. L., Babish J. D. Hospitalizations with adverse events caused by digitalis therapy among elderly Medicare beneficiaries. Arch Intern Med: 1994; 154 13 1482 1487 (Pubitemid 24208573)
    • (1994) Archives of Internal Medicine , vol.154 , Issue.13 , pp. 1482-1487
    • Warren, J.L.1    McBean, A.M.2    Hass, S.L.3    Babish, J.D.4
  • 7
    • 40949139727 scopus 로고    scopus 로고
    • Estimating the extent of reporting to FDA: A case study of statin-associated rhabdomyolysis
    • DOI 10.1002/pds.1535
    • McAdams M., Staffa J., Dal Pan G. Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis. Pharmacoepidemiol Drug Saf: 2008; 17 3 229 239 (Pubitemid 351404034)
    • (2008) Pharmacoepidemiology and Drug Safety , vol.17 , Issue.3 , pp. 229-239
    • MacAdams, M.1    Staffa, J.2    Dal Pan, G.3
  • 8
    • 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 B. H., Corey P. N. 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
  • 9
    • 81855169543 scopus 로고    scopus 로고
    • Emergency hospitalizations for adverse drug events in older Americans
    • Budnitz D. S., Lovegrove M. C., Shehab N., Richards C. L. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med: 2011; 365 21 2002 2012
    • (2011) N Engl J Med , vol.365 , Issue.21 , pp. 2002-2012
    • Budnitz, D.S.1    Lovegrove, M.C.2    Shehab, N.3    Richards, C.L.4
  • 10
    • 70349306707 scopus 로고    scopus 로고
    • Dabigatran versus warfarin in patients with atrial fibrillation
    • Connolly S. J., Ezekowitz M. D., Yusuf S., et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med: 2009; 361 12 1139 1151
    • (2009) N Engl J Med , vol.361 , Issue.12 , pp. 1139-1151
    • Connolly, S.J.1    Ezekowitz, M.D.2    Yusuf, S.3
  • 12
    • 84879919866 scopus 로고    scopus 로고
    • MedDRA Maintenance and Support Services Organization Chantilly, VA MedDRA Maintenance and Support Services Organization
    • MedDRA Maintenance and Support Services Organization Introductory guide to standardised MedDRA queries (SMQs) Version 14.1. Chantilly, VA MedDRA Maintenance and Support Services Organization: 2011
    • (2011) Introductory Guide to Standardised MedDRA Queries (SMQs) Version 14.1
  • 14
    • 84868577020 scopus 로고    scopus 로고
    • A state attorney general and a hematologist facilitate translation of research into US Food and Drug Administration actionsa SONAR report
    • 10.1200/JOP.2011.000504
    • Chen B., Restaino J. R., Sartor A. O., et al. A state attorney general and a hematologist facilitate translation of research into US Food and Drug Administration actionsa SONAR report. J Oncol Pract: 2012; 10.1200/JOP.2011. 000504
    • (2012) J Oncol Pract
    • Chen, B.1    Restaino, J.R.2    Sartor, A.O.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.