Adverse events reported for hereditary angioedema medications: a retrospective study of spontaneous reports submitted to the EudraVigilance database, 2007-2013

References

• Bork K, Meng G, Staubach P, Hardt J. Hereditary angioedema: new findings concerning symptoms, affected organs, and course. Am J Med. 2006;119(3):267–274.
   PubMed Web of Science ®Google Scholar
• Rasmussen ER, Bindslev-Jensen C, Bygum A. Angioedema – assessment and treatment. Tidsskr Nor Legeforen. 2012(21); 2391–2395.
   Google Scholar
• Bowen T, Cicardi M, Farkas H, et al. 2010 International consensus algorithm for the diagnosis, therapy and management of hereditary angioedema. Allergy Asthma Clin Immunol. 2010;6(1):24.
   PubMedGoogle Scholar
• Cicardi M, Bork K, Caballero T, et al. Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012;67(2):147–157.
   PubMed Web of Science ®Google Scholar
• Bork K. Current drugs in early development for hereditary angioedema: potential for effective treatment. Expert Opin Investig Drugs. 2014;23(7):887–891.
   PubMed Web of Science ®Google Scholar
• Bygum A. Hereditary angioedema—consequences of a new treatment paradigm in Denmark. Acta Derm Venereol. 2014;94(4):436–441.
   Web of Science ®Google Scholar
• Wilson DA, Bork K, Shea EP, Rentz AM, Blaustein MB, Pullman WE. Economic costs associated with acute attacks and long-term management of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;104(4):314–320.
   PubMed Web of Science ®Google Scholar
• Eur-Lex.europa.eu [website on the Internet]. Regulation (EC) no. 141/2000 of the European Parliament and of the council of 16 December 1999 on orphan medicinal products; 1999. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2000_141/reg_2000_141_en.pdf. Accessed December 7, 2015.
   Google Scholar
• Craig TJ, Levy RJ, Wasserman RL, et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol. 2009;124(4):801–808.
   PubMed Web of Science ®Google Scholar
• Zuraw B, Cicardi M, Levy RJ, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol. 2010;126(4):821–827.
   PubMed Web of Science ®Google Scholar
• Zuraw BL, Busse PJ, White M, et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010;363(6):513–522.
   PubMed Web of Science ®Google Scholar
• Cicardi M, Banerji A, Bracho F, et al. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010;363(5):532–541.
   Google Scholar
• Lumry WR, Li HH, Levy RJ, et al. Randomized placebo-controlled trial of the bradykinin B2 receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011;107(6):529–537.
   PubMed Web of Science ®Google Scholar
• Cicardi M, Levy RJ, McNeil DL, et al. Ecallantide for the treatment of acute attacks in hereditary angioedema. N Engl J Med. 2010;363(6):523–531.
   PubMed Web of Science ®Google Scholar
• Levy RJ, Lumry WR, McNeil DL, et al. EDEMA4: a phase 3, double-blind study of subcutaneous ecallantide treatment for acute attacks of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;104(6):523–529.
   PubMed Web of Science ®Google Scholar
• Schneider L, Lumry W, Vegh A, Williams AH, Schmalbach T. Critical role of kallikrein in hereditary angioedema pathogenesis: a clinical trial of ecallantide, a novel kallikrein inhibitor. J Allergy Clin Immunol. 2007;120(2):416–422.
   PubMed Web of Science ®Google Scholar
• Aagaard L, Hansen EH. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs. BMC Clin Pharmacol. 2009;9:4.
   PubMedGoogle Scholar
• EU directive of the European Parliament and of the council amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription. COM (2012) 48 final. Brussels; 2012. Available from: http://eur-lex.europa.eu/index.html. Accessed December 7, 2015.
   Google Scholar
• Sabharwal G, Craig T. Recombinant human C1 esterase inhibitor for the treatment of hereditary angioedema due to C1 inhibitor deficiency C1-INH-HAE. Expert Rev Clin Immunol. 2015;11(3):319–327.
   Web of Science ®Google Scholar
• European Medicines Agency: Note for guidance – EudraVigilance Human –Processing of safety messages and individual case safety reports (ICSRs). EMA/H/20665/04/Final Rev 2. Available from: https://eudravigilance.ema.europa.eu/human/docs/guid-P-Technical%20 Documentation-EMEA-H-20665-04-en-Final_Revision_2.pdf. Accessed December 7, 2015.
   Google Scholar
• European Medicines Agency: Volume 9. Pharmacovigilance: medicinal products for human use and veterinary products. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev9.html. Accessed December 7, 2015.
   Google Scholar
• Office Journal of the European Commission. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. L 145/43. Available from: www.europarl.europa.eu/register/pdf/r1049_en.pdf. Accessed December 7, 2015.
   Google Scholar
• Health Action International Europe: Patient reporting of adverse drug reactions – seminar report; 2005. Available from: http://haieurope.org/wp-content/uploads/2015/09/Direct-Patient-Reporting-in-the-EU.pdf. Accessed December 7, 2015.
   Google Scholar
• MedDRA. Available from: http://www.meddra.org/. Accessed December 7, 2015.
   Google Scholar
• Busse P, Bygum A, Edelman J, et al. Safety of c1-esterase inhibitor in acute and prophylactic therapy of hereditary angioedema: findings from the ongoing international Berinert patient registry. J Allergy Clin Immunol Pract. 2015;3(2):213–219.
   PubMed Web of Science ®Google Scholar
• Kalaria S, Craig T. Assessment of hereditary angioedema treatment risks. Allergy Asthma Proc. 2013;34(6):519–522.
   PubMed Web of Science ®Google Scholar
• Zuraw LB, Kalfus I. Safety and efficacy of prophylactic nanofiltered C1-inhibitor in hereditary angioedema. Am J Med. 2012;125(9):938.e1–e7.
   Web of Science ®Google Scholar
• Crowther M, Bauer K, Kaplan AP. The thrombogenicity of C1 esterase inhibitor (human): Review of the evidence. Allergy Asthma Proc. 2014;35(6):444–453.
   PubMed Web of Science ®Google Scholar
• Ghandi PK, Gentry WM, Bottorf MB. Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigations from the United States Food and Drug Administration Adverse Event Reporting System database. Pharmacotherapy. 2012(10);32:902–909.
   Google Scholar
• Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf. 2005;28(9):825–833.
   PubMed Web of Science ®Google Scholar
• Aagaard L, Kristensen K. Access to cross-border health care services for patients with rare diseases in the European Union. Orphan Drugs: Res Rev. 2014:4;39–45.
   Google Scholar
• Westermark K, Holm BB, Söderholm M, et al. European regulation on orphan medicinal products: 10 years of experience and future perspectives. Nat Rev Drug Discov. 2011;10(5):341–349.
   Web of Science ®Google Scholar
• Riedl MA, Lumry WR, Busse P, et al. Prevalence of hereditary angioedema in untested first-degree blood relatives of known subjects with hereditary angioedema. Allergy Asthma Proc. 2015;36(3):206–212.
   Web of Science ®Google Scholar
• Pérez García M, Figueras A. The lack of knowledge about the voluntary reporting system of adverse drug reactions as a major cause of underreporting: direct survey among health professionals. Pharmacoepidemiol Drug Saf. 2011;20(12):1295–1302.
   Web of Science ®Google Scholar
• Kesselheim AS, Gagne JJ. Strategies for postmarketing surveillance of drugs for rare diseases. Clin Pharmacol Ther. 2014;95(3):265–268.
   Web of Science ®Google Scholar