Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions

Authors: Coors, Esther A.; Seybold, Heidi1; Merk, Hans F.2; Mahler, Vera1

Source: Annals of Allergy, Asthma and Immunology, Volume 95, Number 6, December 2005 , pp. 593-599(7)

Publisher: American College of Allergy, Asthma, & Immunology

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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 (eg, 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.

Document Type: Original article

Affiliations: 1: Department of Dermatology, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany. 2: Department of Dermatology, University of Aachen, Aachen, Germany.

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