Abstract
The intravenous administration of E-Ferol in premature infants has been associated with a fatal syndrome of ascltes, splenomegaly, hepatomegaly, cholestatic jaundice, azotemia and thrombocytopenia. This study was undertaken to further delineate the intravenous toxicity of E-Ferol and its vehicle. Albino rabbit pups were delivered at 30 days gestation by c-section under halothane anesthesia. Central venous catheters were placed 2-6 hours after birth and parenteral nutrition was provided for 7 days. Four treatment groups were utilized 1) alpha-tocopherol (AT), 2) alpha-tocopheryl acetate (TA), 3) polysorbate (P) and 4) saline control. The vitamin E preparations were formulated by incorporating 25 mg of TA or AT per ml of vehicle solution comprised of 9% P 80 and 1% P 20. A dose of 4 ml/kg was administered daily. The weight gain of the animals over the 7 day period averaged 1.0 g, −0.1 g, −1.6 g and 3.0 g for groups 1, 2, 3 and 4 respectively. AT concentration was significantly (p<0.01) greater in liver, lung and plasma of animals supplemented with vitamin E. Liver vitamin E levels in supplemented and unsupplemented animals were (mean±SD) 4340±2249 ug/g and 65±25 ug/g respectively while plasma levels were 99±72 ug/ml in supplemented animals and 16±23 ug/ml in unsupplemented animals. There was a trend for higher bilirubin concentrations and Alk Phos activity in group 1, 2 and 3 as compared to saline control. There were no differences in BUN or creatinine concentrations as well as in ALT, and GGT activity amongst the groups. Conclusions: 1) Levels of vitamin E in liver, lung and plasma reflected the specific treatment group 2) Significant accumulation of vitamin E occurred in the liver 3) The limited number of animals studied coupled with a limited nutritional regimen precluded assignment of toxicity to vitamin E versus the polysorbate vehicle.
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Rivera, A., Abdo, K., Bucher, J. et al. A STUDY ON THE INTRAVENOUS TOXICITY OF E-FEROL IN THE NEONATAL RABBIT. Pediatr Res 21 (Suppl 4), 241 (1987). https://doi.org/10.1203/00006450-198704010-00444
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DOI: https://doi.org/10.1203/00006450-198704010-00444