Skip to main content
SpringerLink
Log in

Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work

  • Chapter
  • First Online:
Cancer Drug Safety and Public Health Policy

Part of the book series: Cancer Treatment and Research ((CTAR,volume 184))

  • 260 Accesses

Abstract

Severe adverse drug reactions (sADRs) are important causes of morbidity and mortality. The Southern Network on Adverse Drug Reactions (SONAR), a National Cancer Institute-funded pharmacovigilance program, has outlined a novel 9-stop methodology, termed ANTICIPATE, that has evaluated this methodology, among persons with chronic kidney disease (CKD).

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 159.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  1. Bennett CL, Jacob S, Hymes J, Usvyat LA, Maddux FW (2014) Anaphylaxis and hypotension after administration of peginesatide. N Engl J Med 370:2055–2056

    Article  PubMed  PubMed Central  Google Scholar 

  2. Jacob S, Nichols P, Macdougall IC, Qureshi Z, Chen B, Yant g YT (2018) Investigating serious adverse drug reactions in patients receiving erythropoiesis stimulating agents: a root cause analysis using the ANTICPATE framework. Am J Ther; e670–e674

    Google Scholar 

  3. European Medicines Agency (2014) Pharmacovigilance Department. One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency. May 20, 2014. Accessed 25 March 2019

    Google Scholar 

  4. Bennett CL, Luminari S, Nissenson AR, Tallman MS, Klinge SA, McWilliams N, McKoy JM, Kim B, Lyons EA, Trifilio S, Raisch DW, Evens AM, Kuzel TM, Schumock GT, Belknap SM, Locatelli F, Rossert J, Casadevall N (2004) Pure red-cell aplasia and epoetin Therapy. New Engl J Med 351:1403–1408

    Article  CAS  PubMed  Google Scholar 

  5. Macdougall IC, Casadevall N, Locatelli F, Combe C, London GM, Di Paolo S, Kribben A, Fliser D, Messner H, McNeil J, Stevens P, Santoro A, De Francisco AL, Percheson P, Potamianou A, Foucher A, Fife D, Mérit V, Vercammen E (2015) PRIMS study group. Nephrol Dial Transpl 30:451–460

    Article  CAS  Google Scholar 

  6. Bennett CL, Starko KM, Thomsen HS, Cowper S, Sartor AO, MacDougall I, Qureshi ZP, Bookstaver PB, Miller AD, Norris LB, Xirasagar S, Trenery A, Lopez I, Kahn A, Murday A, Luminari S, Cournoyer D, Locatelli F, Ray P, Mattison DR (2012) Linking drugs to obscure illnesses: lessons from pure red cell aplasia, nephrogenic systemic fibrosis, and Reye’s syndrome. A report from the SOuthern Network on Adverse Reactions (SONAR). J Genl Intern Med 27:1697–1703

    Google Scholar 

  7. Bennett CL, Qureshi ZP, Sartor AO, Norris LB, Murday A, Xirasagar S, Thomsen HS (2012) Gadolinium induced nephrogrenic systemic fibrosis, the rise and fall of an iatrogenic disease. Clin Kidney J 5:82–88

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Elmholdt TR, Olesen AB, Jørgensen B, Kvist S, Skov L, Thomsen HS, Marckmann P, Pedersen M (2013) Nephrogenic systemic fibrosis in Denmark—a nationwide investigation. PLoS ONE 8(12):e82037. https://doi.org/10.1371/journal.pone.0082037

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Elmholdt TR, Pedersen M, Jorgensen B, Sondergaard K, Jensen JD et al (2011) Nephrogenic systemic fibrosis is found only among gadolinium-exposed patients with renal insufficiency: a case-control study from Denmark. Br J Dermatol 165:828–836. https://doi.org/10.1111/j.1365-2133.2011.10465.x[doi]

    Article  CAS  PubMed  Google Scholar 

  10. Rydahl C, Thomsen HS, Marckmann P (2008) High prevalence of nephrogenic systemic fibrosis in chronic renal failure patients exposed to gadodiamide, a gadolinium-containing magnetic resonance contrast agent. Invest Radiol 43:141–144. https://doi.org/10.1097/RLI.0b013e31815a3407[doi];00004424-200802000-00007

    Article  CAS  PubMed  Google Scholar 

  11. Bennett CL, Nebeker JR, Lyons EA, Samore MH, Feldman MD, McKoy JM, Carson KR, Belknap SM, Trifilio SM, Schumock GT, Yarnold PR, Davidson CJ, Evens AM, Kuzel TM, Parada JP, Cournoyer D, West DP, Sartor O, Tallman MS, Raisch DW (2005) The Research on Adverse Drug Events and Reports (RADAR) project. JAMA 293:2131–2140

    Article  CAS  PubMed  Google Scholar 

  12. Haag-Weber M, Eckhardt K-U, Horl WH, Roger SD, Vetter A, Roth K (2012) Safety, immunogenicity, and efficacy of a subcutaneous biosimilar epoetin-alfa (HX575) in non-dialysis patients with renal anemia: a multi-center randomized double-blind study. Clin Nephrol 77:8–17

    Article  CAS  PubMed  Google Scholar 

  13. Marckmann P, Skov L, Rossen K, Dupont A, Damholt MB, Heaf JG, Thomsen HS (2006) J Am Soc Nephrol 17:2359–2362

    Article  PubMed  Google Scholar 

  14. Seidl A, Richter M, Fischer R et al (2012) Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res 29:1454–1467

    Article  CAS  PubMed  Google Scholar 

  15. Grobner T (2006) Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transpl 21:1104–1108

    Article  CAS  Google Scholar 

  16. Introcaso CE, Hivnor C, Cowper S, Werth VP (2007) Nephrogenic fibrosing dermopathy/nephrogenic systemic fibrosis: a case series of nine patients and review of the literature. Int J Dermatol 46(5):447–452

    Article  PubMed  Google Scholar 

  17. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P (2002) Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 346:469–475

    Article  CAS  PubMed  Google Scholar 

  18. Hermanson T, Bennett CL, Macdougall IC (2016) Peginesatide for the treatment of anemia due to chronic kidney disease - an unfulfilled promise. Expert Opin Drug Saf 15(10):1421–1426. https://doi.org/10.1080/14740338.2016.1218467

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Withdrawal assessment report for Omontys. European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/09/WC500148933.pdf. Accessed 25 March 2019

  20. Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S, PEARL Study Groups (2013) Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med 368(4):320–332. https://doi.org/10.1056/NEJMoa1203166

  21. Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307–19. https://doi.org/10.1056/NEJMoa1203165.

  22. Cournoyer D, Toffelmire EB, Wells GA, Barber DL, Barrett BJ, Delage R, Forrest DL, Gagnon RF, Harvey EA, Laneuville P, Patterson BJ, Poon MC, Posen GA, Messner HA, Canadian PRCA Focus Group (2004) Anti-erythropoietin antibody-mediated pure red cell aplasia after treatment with recombinant erythropoietin products: recommendations for minimization of risk. J Am Soc Nephrol 15:2728–2734

    Google Scholar 

  23. Elmholdt TR et al (2013) Nephrogenic system fibrosis in Denmark—a nationwide investigation. PLoS ONE 12:e82307

    Google Scholar 

  24. Trontell A (2004) Expecting the unexpected—drug safety, pharmacovigilance, and the prepared mind. N Engl J Med 351:1385–1387

    Article  CAS  PubMed  Google Scholar 

  25. Wood AJ (2000) Thrombotic thrombocytopenic purpura and clopidogrel—a need for new approaches to drug safety. N Engl J Med 342:1824–1826

    Article  CAS  PubMed  Google Scholar 

  26. Weaver JL, Boyne M, Pang E, Chimalakonda K, Howard KE (2015) Nonclinical evaluation of the potential for mast cell activation by an erythropoietin analog. Toxicol Appl Pharmacol pii:S0041–008X(15)30017-X. https://doi.org/10.1016/j.taap.2015.06.009. [Epub ahead of print]

  27. Zhou Z, Bupp S, Kozlowski A (2015) Developing in vitro and in vivo models to predict drug-induced acute allergic reactions. Proceedings of the 2015 FDA science forum on emerging technologies. Bethesda, Maryland. http://www.fda.gov/downloads/ScienceResearch/AboutScienceResearchatFDA/UCM447461.pdf. Accessed 15 Jun 2022

  28. Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU (2009) A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med 361(19):1848–1855. https://doi.org/10.1056/NEJMoa074037

  29. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P (2002) Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 346(7):469–475

    Article  CAS  PubMed  Google Scholar 

  30. Macdougall IC, Roger SD, de Francisco A, Goldsmith DJ, Schellekens H, Ebbers H, Jelkmann W, London G, Casadevall N, Hörl WH, Kemeny DM, Pollock C (2012) Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights. Kidney Int 81(8):727–732. https://doi.org/10.1038/ki.2011.500. Epub 2012 Feb 15

  31. Kishimoto TK, Viswanathan K, Ganguly T et al (2008) Contaminated heparin-associated with adverse clinical events and activation of the contact system. N Engl J Med 358:2457–2467

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. SONAR (Southern Network on Adverse Reactions) Program, University of South Carolina College of Pharmacy, Columbia, SC, 29208, USA

    Charles L. Bennett & Shamia Hoque

Authors
  1. Charles L. Bennett
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Shamia Hoque
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Shamia Hoque .

Editor information

Editors and Affiliations

  1. College of Pharmacy, University of South Carolina, Columbia, SC, USA

    Charles Bennett

  2. College of Pharmacy, University of South Carolina, Columbia, SC, USA

    Courtney Lubaczewski

  3. College of Pharmacy, University of South Carolina, Columbia, SC, USA

    Bartlett Witherspoon

Rights and permissions

Reprints and permissions

Copyright information

© 2022 The Author(s), under exclusive license to Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Bennett, C.L., Hoque, S. (2022). Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work. In: Bennett, C., Lubaczewski, C., Witherspoon, B. (eds) Cancer Drug Safety and Public Health Policy. Cancer Treatment and Research, vol 184. Springer, Cham. https://doi.org/10.1007/978-3-031-04402-1_9

Download citation

  • DOI: https://doi.org/10.1007/978-3-031-04402-1_9

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-04401-4

  • Online ISBN: 978-3-031-04402-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation