Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions.
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.
Coors
Esther A
EA
Department of Dermatology, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany.
Seybold
Heidi
H
Merk
Hans F
HF
Mahler
Vera
V
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*
D004364:Pharmaceutical Preparations; D011136:Polysorbates; D013501:Surface-Active Agents; D014815:Vitamins; D007073:Immunoglobulin E