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Vasculopathic Hepatotoxicity Associated With E-Ferol Syndrome in Low—Birth-Weight Infants
Kevin E. Bove, MD;
Niki Kosmetatos, MD;
Kathryn E. Wedig, MD;
Donald J. Frank, MD;
Stephen Whitlatch, MD;
Victor Saldivar, MD;
Joel Haas, MD;
Carl Bodenstein, MD;
William F. Balistreri, MD
JAMA. 1985;254(17):2422-2430.
Abstract
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A fatal syndrome characterized by progressive clinical deterioration with unexplained thrombocytopenia, renal dysfunction, cholestasis, and ascites developed in certain infants throughout the United States who had received E-Ferol, an intravenous vitamin E supplement. We reviewed the clinical course of all 36 infants from one (index) nursery who had received E-Ferol, which contains 25 units per milliliter of dl- -tocopheryl acetate solubilized with 9% polysorbate 80 and 1% polysorbate 20. The syndrome was recognized in eight of the 36 infants; affected infants had a lower birth weight (<1,200 g) and had received a higher total dose of E-Ferol for longer periods than the unaffected cases. We reviewed autopsy-derived tissue from 20 infants (six from the index nursery and 14 from three other collaborating nurseries) who had received the intravenous vitamin E preparation in a reported dose of 25 to 137 units/kg/day for six to 45 days between October 1983 and March 1984. The hepatic histology in the affected cases indicated a progressive injury characterized initially by Kupffer cell exfoliation, central lobular accumulation of cellular debris, and centrally accentuated panlobular congestion. Prolonged exposure to E-Ferol was associated with progressive intralobular cholestasis, inflammation of hepatic venules, and extensive sinusoidal veno-occlusion by fibrosis. We propose that vasculocentric hepatotoxicity is the basis for the observed clinical syndrome that represents the cumulative effect of one or more of the constituents of E-Ferol.
(JAMA 1985;254:2422-2430)
Author Affiliations
From the Children's Hospital Medical Center (Drs Bove and Balistreri) and Good Samaritan Hospital (Drs Kosmetatos, Wedig, Frank, and Whitlatch), Cincinnati; Santa Rosa Hospital, San Antonio, Tex (Dr Saldivar); Children's Orthopedic Hospital and Medical Center, Seattle (Dr Haas); and Sacred Heart Hospital, Spokane, Wash (Dr Bodenstein).
Footnotes
Reprint requests to Division of Pediatric Gastroenterology and Nutrition, Children's Hospital Research Foundation, Elland and Bethesda avenues, Cincinnati, OH 45229 (Dr Balistreri).
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