PEDIATRICS Vol. 77 No. 4 April 1986, pp. 593-597
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Polysorbate 80 and E-Ferol Toxicity

Solomon L. Alade PhD1, R. E. Brown MD1, and Andrew Paquet Jr PhD1

1 From the Department of Pathology, Cook-Fort Worth Children's Medical Center, and Department of Biology, Texas Christian University, Fort Worth

The relatively recent introduction and use of an intravenous form of a vitamin E preparation (E-Ferol) has been associated with the development of an unusual syndrome and fatalities among low birth weight (<1,500 g), premature infants in neonatal intensive care units. We have observed an inhibitory effect by this vitamin E preparation on the in vitro response of human lymphocytes to phytohemagglutinin (PHA). E-Ferol suppressed the expected response to low doses of PHA. However, this suppression was not due to the agr-tocopherol acetate (vitamin E) component, because agr-tocopherol acetate by itself was not inhibitory; in fact, it often enhanced the PHA response. Because a mixture of polysorbate 80 and polysorbate 20 is used as a carrier in E-Ferol, these components were also tested and were found to be responsible for the suppression, especially the polysorbate 80. Concurrent with this suppression of PHA-induced mitogenesis was a decrease in the percentage of T11 lymphocytes.

Key Words: vitamin E • agr-tocopherol • polysorbate 80 • phytohemagglutinin • mitogenesis

Accepted on November 18, 1985


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