title: Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions.
abstract: BACKGROUND
  Polyoxyethylene-sorbitan-20-monooleate (also known as polysorbate 80 and Tween 80) is a solubilizing agent ubiquitously used in nutritives, creams, ointments, lotions, and multiple medical preparations (e.g., vitamin oils, vaccines, and anticancer agents) and as an additive in tablets. Whereas its relevance as a contact allergen has declined during the past decades, it is of current relevance as a "hidden" inductor of anaphylactoid reactions.
  
  
  OBJECTIVE
  To identify polysorbate 80 (generally believed to be an inert vehicle) as an inductor of a severe anaphylactoid reaction.
  
  
  METHODS
  Skin prick testing, enzyme-linked immunosorbent assay, IgE immunoblotting, and flow cytometric detection of basophil activation were performed in controls and in a patient with a medical history of anaphylactic shock due to intravenous administration of a multivitamin product during pregnancy.
  
  
  RESULTS
  Polysorbate 80 was identified as the causative agent for the anaphylactoid reaction of nonimmunologic origin in the patient. Polysorbate specific IgE antibodies were not identified in enzyme-linked immunosorbent assay and immunoblot examinations, confirming the nonimmunologic nature of the anaphylactoid reaction.
  
  
  CONCLUSIONS
  Polysorbate 80 is a ubiquitously used solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions.
authors.affiliation: Department of Dermatology, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany.
authors.forename: Esther A
authors.initials: EA
authors.lastname: Coors
authors.forename: Heidi
authors.initials: H
authors.lastname: Seybold
authors.forename: Hans F
authors.initials: HF
authors.lastname: Merk
authors.forename: Vera
authors.initials: V
authors.lastname: Mahler
mesh_terms: D000707:Anaphylaxis / Q000139:chemically induced* / Q000276:immunology; D001491:Basophils / Q000276:immunology; D064420:Drug-Related Side Effects and Adverse Reactions; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D015151:Immunoblotting; D007073:Immunoglobulin E / Q000097:blood; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011136:Polysorbates / Q000009:adverse effects* / Q000737:chemistry; D011247:Pregnancy; D012882:Skin Tests; D013501:Surface-Active Agents / Q000009:adverse effects* / Q000737:chemistry; D014815:Vitamins / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry*
chemical_list: D004364:Pharmaceutical Preparations; D011136:Polysorbates; D013501:Surface-Active Agents; D014815:Vitamins; D007073:Immunoglobulin E