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Volumn 55, Issue , 2015, Pages S28-S35

Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN; IMMUNOLOGIC FACTOR;

EID: 84942465461     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/TRF.13116     Document Type: Article
Times cited : (17)

References (29)
  • 1
    • 0026422422 scopus 로고
    • The use of intravenous immune globulin in immunodeficiency diseases
    • Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med 1991;325: 110-7.
    • (1991) N Engl J Med , vol.325 , pp. 110-117
    • Buckley, R.H.1    Schiff, R.I.2
  • 2
    • 33645341439 scopus 로고    scopus 로고
    • Use of intravenous immunoglobulin in human disease: A review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology
    • Suppl
    • Orange JS, Hossny EM, Weiler CR, et al. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol 2006;117(4 Suppl):S525-53.
    • (2006) J Allergy Clin Immunol , vol.117 , Issue.4 , pp. S525-S553
    • Orange, J.S.1    Hossny, E.M.2    Weiler, C.R.3
  • 3
    • 84869431305 scopus 로고    scopus 로고
    • Intravenous immune globulin in autoimmune and inflammatory diseases
    • Gelfand EW. Intravenous immune globulin in autoimmune and inflammatory diseases. N Engl J Med 2012;367:2015-25.
    • (2012) N Engl J Med , vol.367 , pp. 2015-2025
    • Gelfand, E.W.1
  • 4
    • 85138171258 scopus 로고    scopus 로고
    • Silver Spring (MD): US Food and Drug Administration; last updated 2015 Jan 30 [cited 2014 Oct 20]. Available from
    • CBER-regulated products: current shortages [Internet]. Silver Spring (MD): US Food and Drug Administration; last updated 2015 Jan 30 [cited 2014 Oct 20]. Available from: http://www.fda.gov/biologicsbloodvaccines/safetyavailabil-ity/shortages/ucm351921.htm
  • 5
    • 73649119908 scopus 로고    scopus 로고
    • Intravenous immunoglobulin G: Trends in production methods, quality control and quality assurance
    • Radosevich M, Burnouf T. Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance. Vox Sang 2010;98:12-28.
    • (2010) Vox Sang , vol.98 , pp. 12-28
    • Radosevich, M.1    Burnouf, T.2
  • 6
    • 84891738724 scopus 로고    scopus 로고
    • Anti-A and anti-B haemagglutinin levels in intravenous immunoglobulins: Are they on the rise? A comparison of four different analysis methods and six products
    • Bellac CL, Polatti D, Hottiger T, et al. Anti-A and anti-B haemagglutinin levels in intravenous immunoglobulins: are they on the rise? A comparison of four different analysis methods and six products. Biologicals 2014;42:57-64.
    • (2014) Biologicals , vol.42 , pp. 57-64
    • Bellac, C.L.1    Polatti, D.2    Hottiger, T.3
  • 7
    • 73649144493 scopus 로고    scopus 로고
    • Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients
    • Kahwaji J, Barker E, Pepkowitz S, et al. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol 2009;4:1993-7.
    • (2009) Clin J am Soc Nephrol , vol.4 , pp. 1993-1997
    • Kahwaji, J.1    Barker, E.2    Pepkowitz, S.3
  • 8
    • 0023003697 scopus 로고
    • Hemolysis following intravenous immune globulin therapy
    • Copelan EA, Strohm PL, Kennedy MS, et al. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26:410-2.
    • (1986) Transfusion , vol.26 , pp. 410-412
    • Copelan, E.A.1    Strohm, P.L.2    Kennedy, M.S.3
  • 9
    • 0030803022 scopus 로고    scopus 로고
    • Hemolytic anemia asso-ciated with intravenous immunoglobulin
    • Wilson JR, Bhoopalam H, Fisher M. Hemolytic anemia asso-ciated with intravenous immunoglobulin. Muscle Nerve 1997;20:1142-5.
    • (1997) Muscle Nerve , vol.20 , pp. 1142-1145
    • Wilson, J.R.1    Bhoopalam, H.2    Fisher, M.3
  • 10
    • 48249083046 scopus 로고    scopus 로고
    • Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: A case series analysis
    • Daw Z, Padmore R, Neurath D,et al. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion 2008; 48:1598-601.
    • (2008) Transfusion , vol.48 , pp. 1598-1601
    • Daw, Z.1    Padmore, R.2    Neurath, D.3
  • 11
    • 85138143669 scopus 로고    scopus 로고
    • Canadian Adverse Reaction Newsletter 19[4]. Ottawa: Health Canada; c2009 [cited 2014 Oct 21]
    • Taylor E. Intravenous immune globulin (IGIV): hemolytic reactions [Internet]. Canadian Adverse Reaction Newsletter 19[4]. Ottawa: Health Canada; c2009 [cited 2014 Oct 21]. Available from: http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v19n4-eng.php#a1.
    • Intravenous Immune Globulin (IGIV): Hemolytic Reactions [Internet]
    • Taylor, E.1
  • 12
    • 84871208953 scopus 로고    scopus 로고
    • last updated 2014 Sep 8 [cited 2014 Sep 18]
    • FDA adverse event reporting system (FAERS) [Internet]. Silver Spring (MD): US Food and Drug Administration; last updated 2014 Sep 8 [cited 2014 Sep 18]. Available from: http://www.fda.gov/drugs/guidancecomplianceregulatoryin-formation/surveillance/adversedrugeffects
    • Silver Spring (MD): US Food and Drug Administration
  • 14
    • 84857447481 scopus 로고    scopus 로고
    • Hemolysis upon intravenous immunoglobulin transfusion
    • Padmore RF. Hemolysis upon intravenous immunoglobulin transfusion. Transfus Apher Sci 2012;46:93-6.
    • (2012) Transfus Apher Sci , vol.46 , pp. 93-96
    • Padmore, R.F.1
  • 15
    • 84863393033 scopus 로고    scopus 로고
    • The organiza-tional structure and governing principles of the Food and Drug Administration’s Mini-Sentinel pilot program
    • Forrow S, Campion DM, Herrinton LJ, et al. The organiza-tional structure and governing principles of the Food and Drug Administration’s Mini-Sentinel pilot program. Pharma-coepidemiol Drug Saf 2012;21 Suppl 1:12-7.
    • (2012) Pharma-Coepidemiol Drug Saf , vol.21 , pp. 12-17
    • Forrow, S.1    Campion, D.M.2    Herrinton, L.J.3
  • 16
    • 85138171394 scopus 로고    scopus 로고
    • Rock-ville (MD): US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER), cited 2014 Oct 21
    • Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment [Internet]. Rock-ville (MD): US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER); 2005 [cited 2014 Oct 21]. Available from: http://www.fda.gov/downloads/RegulatoryInforma-tion/Guidances/ucm126834.pdf
    • (2005)
  • 17
    • 84862932391 scopus 로고    scopus 로고
    • The US Food and Drug Administration’s Mini-Sentinel program: Status and direction
    • Platt R, Carnahan RM, Brown JS, et al. The US Food and Drug Administration’s Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012;21 Suppl 1:1-8.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , pp. 1-8
    • Platt, R.1    Carnahan, R.M.2    Brown, J.S.3
  • 19
    • 0027968619 scopus 로고
    • Evidence of the depletion of suscep-tibles effect in non-experimental pharmacoepidemiologic research
    • Moride Y, Abenhaim L. Evidence of the depletion of suscep-tibles effect in non-experimental pharmacoepidemiologic research. J Clin Epidemiol 1994;47:731-7.
    • (1994) J Clin Epidemiol , vol.47 , pp. 731-737
    • Moride, Y.1    Abenhaim, L.2
  • 20
    • 20444382794 scopus 로고    scopus 로고
    • Anti-A and anti-B activity in batches of different intravenous immunoglobulin products determined using a direct haemagglutination method
    • Thorpe SJ, Fox BJ, Dolman CD, et al. Anti-A and anti-B activity in batches of different intravenous immunoglobulin products determined using a direct haemagglutination method. Biologicals 2005;33:111-6.
    • (2005) Biologicals , vol.33 , pp. 111-116
    • Thorpe, S.J.1    Fox, B.J.2    Dolman, C.D.3
  • 21
    • 65649085969 scopus 로고    scopus 로고
    • Epidemiologic vari-ability of chronic inflammatory demyelinating polyneurop-athy with different diagnostic criteria: Study of a UK population
    • Rajabally YA, Simpson BS, Beri S, et al. Epidemiologic vari-ability of chronic inflammatory demyelinating polyneurop-athy with different diagnostic criteria: study of a UK population. Muscle Nerve 2009;39:432-8.
    • (2009) Muscle Nerve , vol.39 , pp. 432-438
    • Rajabally, Y.A.1    Simpson, B.S.2    Beri, S.3
  • 22
    • 50449106113 scopus 로고    scopus 로고
    • Prevalence and incidence rates of chronic inflammatory demyelinating polyneurop-athy in the Japanese population
    • Iijima M, Koike H, Hattori N, et al. Prevalence and incidence rates of chronic inflammatory demyelinating polyneurop-athy in the Japanese population. J Neurol Neurosurg Psychi-atry 2008;79:1040-3.
    • (2008) J Neurol Neurosurg Psychi-Atry , vol.79 , pp. 1040-1043
    • Iijima, M.1    Koike, H.2    Hattori, N.3
  • 23
    • 84862155811 scopus 로고    scopus 로고
    • Guillain-Barre syndrome
    • Yuki N, Hartung HP. Guillain-Barre syndrome. N Engl J Med 2012;366:2294-304.
    • (2012) N Engl J Med , vol.366 , pp. 2294-2304
    • Yuki, N.1    Hartung, H.P.2
  • 24
    • 0041732014 scopus 로고    scopus 로고
    • Kawasaki syndrome hospitalizations in the United States, 1997 and 2000
    • Holman RC, Curns AT, Belay ED, et al. Kawasaki syndrome hospitalizations in the United States, 1997 and 2000. Pedia-trics 2003;112(3 Pt 1):495-501.
    • (2003) Pedia-Trics , vol.112 , Issue.3 , pp. 495-501
    • Holman, R.C.1    Curns, A.T.2    Belay, E.D.3
  • 25
    • 7544222055 scopus 로고    scopus 로고
    • Diagnosis, treatment, and long-term management of Kawasaki disease: A statement for health professionals from the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association
    • Newburger JW, Takahashi M, Gerber MA, et al. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association. Circulation 2004;110:2747-71.
    • (2004) Circulation , vol.110 , pp. 2747-2771
    • Newburger, J.W.1    Takahashi, M.2    Gerber, M.A.3
  • 26
    • 85138147763 scopus 로고    scopus 로고
    • 5% Liq-uid Preparation [Internet]. Silver Spring (MD): US Food and Drug Administration; 2010 Sep 23 [cited 2014 Oct 22]
    • Urgent: voluntary market withdrawal—September 23, 2010 Octagam [Immune Globulin Intravenous (Human)] 5% Liq-uid Preparation [Internet]. Silver Spring (MD): US Food and Drug Administration; 2010 Sep 23 [cited 2014 Oct 22]. Available from: http://www.fda.gov/biologicsbloodvaccines/safe-tyavailability/recalls/ucm227133.htm
    • Urgent: Voluntary Market withdrawal—September 23, 2010 Octagam
  • 27
    • 85138149969 scopus 로고    scopus 로고
    • [Internet]. Washington (DC): US Govern-ment Publishing Office; 2007 Sep 27 [cited 2014 Oct 22]
    • Public Law 110-85 [Internet]. Washington (DC): US Govern-ment Publishing Office; 2007 Sep 27 [cited 2014 Oct 22] Available from: www.gpo.gov/fdsys/pkg/PLAW-110publ85/ pdf/PLAW-110publ85.pdf
  • 28
    • 85138160708 scopus 로고    scopus 로고
    • Silver Spring (MD): US Food and Drug Administration; 2013 Nov 14 [cited 2014 Oct 22]. Available from
    • FDA safety communication: new boxed warning for throm-bosis related to human immune globulin products [Inter-net]. Silver Spring (MD): US Food and Drug Administration; 2013 Nov 14 [cited 2014 Oct 22]. Available from: http://www. fda.gov/biologicsbloodvaccines/safetyavailability/ucm375096.htm
  • 29
    • 85138162339 scopus 로고    scopus 로고
    • Silver Spring (MD): US Food and Drug Administration; last updated 2014 Jul 10 [cited 2014 Oct 22]. Available from
    • Potential signals of serious risks/new safety information identified by the Adverse Event Reporting System (AERS) between January-March 2012 [Internet]. Silver Spring (MD): US Food and Drug Administration; last updated 2014 Jul 10 [cited 2014 Oct 22]. Available from: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveil-lance/adversedrugeffects/ucm307608.htm


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.