title: Low allergenic potential with fondaparinux: results of a prospective investigation.
abstract: OBJECTIVE
  To determine the incidence and causes of skin reactions to the synthetic pentasaccharide fondaparinux.
  
  
  METHODS
  Patients who received prophylactic/therapeutic subcutaneous fondaparinux treatment for more than 7 days were prospectively examined for cutaneous adverse effects between September 1, 2008, and April 30, 2009. When indicated, other procedures, such as skin biopsy, allergy testing, and clinical/laboratory assessment for thrombosis and heparin-induced thrombocytopenia, were performed.
  
  
  RESULTS
  Overall, 231 patients were enrolled. No patient developed typical delayed type IV hypersensitivity (DTH) erythematous skin lesions. However, one female patient experienced abdominal pruritus at sites of injection. Histology revealed a mild lymphohistiocytic infiltrate, confirming a DTH reaction. Heparin-induced thrombocytopenia, as another possible underlying pathomechanism for cutaneous lesions, was ruled out clinically and serologically. Hence, the overall incidence of fondaparinux-induced allergic skin lesions was 0.4% (95% confidence interval, 0.01%-2.4%). No cross-allergies were observed in patients with DTH reaction to heparins.
  
  
  CONCLUSIONS
  Fondaparinux has a low allergenic potential. The incidence of allergic cutaneous DTH reactions is almost 20 times lower compared to that with commonly used heparins. These results, together with the known low prevalence of secondary thrombotic events or heparin-induced thrombocytopenia during fondaparinux therapy, suggest that in selected patients fondaparinux might substantially improve patient care, therapeutic safety, and cost-effectiveness of anticoagulant therapy.
  
  
  BACKGROUND
  clinicaltrials.gov identifier: NCT00510432.
authors.affiliation: Department of Internal Medicine, J. W. Goethe University Hospital, Theodor-Stern-Kai 7, Bldg. 13A, 60590 Frankfurt am Main, Germany. marcschindewolf@kgu.de
authors.forename: Marc
authors.initials: M
authors.lastname: Schindewolf
authors.forename: Julia
authors.initials: J
authors.lastname: Scheuermann
authors.forename: Hartmut
authors.initials: H
authors.lastname: Kroll
authors.forename: Jurate
authors.initials: J
authors.lastname: Garbaraviciene
authors.forename: Carola
authors.initials: C
authors.lastname: Hecking
authors.forename: Ingo
authors.initials: I
authors.lastname: Marzi
authors.forename: Manfred
authors.initials: M
authors.lastname: Wolter
authors.forename: Roland
authors.initials: R
authors.lastname: Kaufmann
authors.forename: Wolf-Henning
authors.initials: WH
authors.lastname: Boehncke
authors.forename: Edelgard
authors.initials: E
authors.lastname: Lindhoff-Last
authors.forename: Ralf J
authors.initials: RJ
authors.lastname: Ludwig
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects; D001706:Biopsy; D004305:Dose-Response Relationship, Drug; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005170:Factor X; D005260:Female; D005500:Follow-Up Studies; D000077425:Fondaparinux; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D017762:Nadroparin / Q000009:adverse effects* / Q000627:therapeutic use; D011134:Polysaccharides / Q000008:administration & dosage*; D011379:Prognosis; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000188:drug therapy*; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects / Q000473:pathology; D012882:Skin Tests
chemical_list: D000925:Anticoagulants; D017762:Nadroparin; D011134:Polysaccharides; D005170:Factor X; D000077425:Fondaparinux