메뉴 건너뛰기




Volumn 76, Issue 5, 2011, Pages 365-372

Intravenous gammaglobulin-associated renal impairment reported to the FDA: 2004-2009

Author keywords

Fda; Hemodialysis; Renal impairment; Sucrose

Indexed keywords

GLYCINE; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; MALTOSE; PROLINE; SORBITOL; SUCROSE;

EID: 82155173035     PISSN: 03010430     EISSN: None     Source Type: Journal    
DOI: 10.5414/CN106824     Document Type: Article
Times cited : (17)

References (21)
  • 1
    • 84856795188 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. Dear Doctor Letter IMPORTANT DRUG WARNING - Potential risk of ACUTE RENAL FAILURE reported to be associated with administration of Immune Globulin Intravenous (Human), (last accessed 1/3/09)
    • U.S. Food and Drug Administration. Dear Doctor Letter IMPORTANT DRUG WARNING - Potential risk of ACUTE RENAL FAILURE reported to be associated with administration of Immune Globulin Intravenous (Human). http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm105901.htm (last accessed 1/3/09).
  • 2
    • 72149125317 scopus 로고    scopus 로고
    • Clinical applications of intravenous immunoglobulins (IVIg) - beyond immunodeficiencies and neurology
    • Hartung HP, Mouthon L, Ahmed R, Jordan S, Laupland KB, Jolles S. Clinical applications of intravenous immunoglobulins (IVIg) - beyond immunodeficiencies and neurology. Clin Exp Immunol. 2009; 158 (Suppl 1): 23-33.
    • (2009) Clin Exp Immunol , vol.158 , Issue.SUPPL 1 , pp. 23-33
    • Hartung, H.P.1    Mouthon, L.2    Ahmed, R.3    Jordan, S.4    Laupland, K.B.5    Jolles, S.6
  • 3
    • 75749083746 scopus 로고    scopus 로고
    • Deciphering antibodymediated rejection: new insights into mechanisms and treatment
    • Stegall MD, Gloor JM. Deciphering antibodymediated rejection: new insights into mechanisms and treatment. Curr Opin Organ Transplant. 2010; 15: 8-10.
    • (2010) Curr Opin Organ Transplant , vol.15 , pp. 8-10
    • Stegall, M.D.1    Gloor, J.M.2
  • 4
    • 69749126241 scopus 로고    scopus 로고
    • Clinical risk management of Stevens-Johnson syndrome/toxic epidermal necrolysis spectrum
    • Knowles S, Shear NH. Clinical risk management of Stevens-Johnson syndrome/toxic epidermal necrolysis spectrum. Dermatol Ther. 2009; 22: 441-451.
    • (2009) Dermatol Ther , vol.22 , pp. 441-451
    • Knowles, S.1    Shear, N.H.2
  • 5
    • 70249103810 scopus 로고    scopus 로고
    • Intravenous immunoglobulin therapy for autoimmune diseases
    • Arnson Y, Shoenfeld Y, Amital H. Intravenous immunoglobulin therapy for autoimmune diseases. Autoimmunity. 2009; 42: 553-560.
    • (2009) Autoimmunity , vol.42 , pp. 553-560
    • Arnson, Y.1    Shoenfeld, Y.2    Amital, H.3
  • 6
    • 70349679090 scopus 로고    scopus 로고
    • Monoclonal gammopathy and neuropathy
    • Ramchandren S, Lewis RA. Monoclonal gammopathy and neuropathy. Curr Opin Neurol. 2009; 22: 480-485.
    • (2009) Curr Opin Neurol , vol.22 , pp. 480-485
    • Ramchandren, S.1    Lewis, R.A.2
  • 7
    • 67651027514 scopus 로고    scopus 로고
    • Intravenous immunoglobulin a natural regulator of immunity and inflammation
    • Jordan SC, Toyoda M, Vo AA. Intravenous immunoglobulin a natural regulator of immunity and inflammation. Transplantation. 2009; 88: 1-6.
    • (2009) Transplantation , vol.88 , pp. 1-6
    • Jordan, S.C.1    Toyoda, M.2    Vo, A.A.3
  • 8
    • 67349200765 scopus 로고    scopus 로고
    • Intravenous immunoglobulins in autoimmune and inflammatory disorders: beyond a simple substitution
    • Galeotti C, Maddur MS, Kazatchkine MD, Mouthon L, Kaveri SV. Intravenous immunoglobulins in autoimmune and inflammatory disorders: beyond a simple substitution. Transfus Clin Biol. 2009; 16: 75-79.
    • (2009) Transfus Clin Biol , vol.16 , pp. 75-79
    • Galeotti, C.1    Maddur, M.S.2    Kazatchkine, M.D.3    Mouthon, L.4    Kaveri, S.V.5
  • 9
    • 84856795191 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act, (last accessed 3/16/10)
    • U.S. Food and Drug Administration. User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122936.htm (last accessed 3/16/10).
  • 10
    • 84856808927 scopus 로고    scopus 로고
    • The Adverse Event Reporting System (AERS) Latest Quarterly Data Files, (last accessed 1/3/09)
    • The Adverse Event Reporting System (AERS) Latest Quarterly Data Files. http://www.fda.gov/cder/aers/extract.htm (last accessed 1/3/09).
  • 11
    • 0032991290 scopus 로고    scopus 로고
    • The medical dictionary for regulatory activities (MedDRA)
    • Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999; 20: 109-117.
    • (1999) Drug Saf , vol.20 , pp. 109-117
    • Brown, E.G.1    Wood, L.2    Wood, S.3
  • 12
    • 84856808928 scopus 로고    scopus 로고
    • MedDRA FAQ, (last accessed 1/3/10)
    • MedDRA FAQ. https://meddramsso.com/public_ faq_meddra.asp (last accessed 1/3/10).
  • 13
    • 84856799408 scopus 로고    scopus 로고
    • U.S. Office of Special Counsel, (last accessed 1/30/10)
    • U.S. Office of Special Counsel. Freedom of Information Act (FOIA) Handbook http://www.osc.gov/foia.htm (last accessed 1/30/10).
    • Freedom of Information Act (FOIA) Handbook
  • 14
    • 84856801426 scopus 로고    scopus 로고
    • Talecris Biotherapeutics, (last accessed 1/3/10)
    • Talecris Biotherapeutics. The history of Talecris. http://www.talecris.com/talecris-history.htm (last accessed 1/3/10).
    • The history of Talecris
  • 15
    • 29944432284 scopus 로고    scopus 로고
    • Intravenous immunoglobulin: adverse effects and safe administration
    • Orbach H, Katz U, Sherer Y, Shoenfeld Y. Intravenous immunoglobulin: adverse effects and safe administration. Clin Rev Allergy Immunol. 2005; 29: 173-184.
    • (2005) Clin Rev Allergy Immunol , vol.29 , pp. 173-184
    • Orbach, H.1    Katz, U.2    Sherer, Y.3    Shoenfeld, Y.4
  • 18
    • 40949146594 scopus 로고    scopus 로고
    • Safety of intravenous immunoglobulin in the treatment of juvenile dermatomyositis: adverse reactions are associated with immunoglobulin A content
    • Published online February 25, 2008
    • Manlhiot C, Tyrrell PN, Liang L, Atkinson AR, Lau W, Feldman BM. Safety of intravenous immunoglobulin in the treatment of juvenile dermatomyositis: adverse reactions are associated with immunoglobulin A content. Pediatrics. 2008; 121: 626-630. Published online February 25, 2008.
    • (2008) Pediatrics , vol.121 , pp. 626-630
    • Manlhiot, C.1    Tyrrell, P.N.2    Liang, L.3    Atkinson, A.R.4    Lau, W.5    Feldman, B.M.6
  • 19
    • 33644836206 scopus 로고    scopus 로고
    • Voluntary electronic reporting of medical errors and adverse events. An analysis of 92,547 reports from 26 acute care hospitals
    • Milch CE, Salem DN, Pauker SG, Lundquist TG, Kumar S, Chen J. Voluntary electronic reporting of medical errors and adverse events. An analysis of 92,547 reports from 26 acute care hospitals. J Gen Intern Med. 2006; 21: 165-170.
    • (2006) J Gen Intern Med , vol.21 , pp. 165-170
    • Milch, C.E.1    Salem, D.N.2    Pauker, S.G.3    Lundquist, T.G.4    Kumar, S.5    Chen, J.6
  • 20
    • 84856808929 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation Analysis of supply, distribution, demand, and access issues associated with immune globulin intravenous (IGIV), (last accessed Sept 9)
    • U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation Analysis of supply, distribution, demand, and access issues associated with immune globulin intravenous (IGIV) http://aspe.hhs.gov/sp/reports/2007/IGIV/report.pdf (last accessed Sept 9, 2009).
    • (2009)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.