Morbidity and mortality among low birth weight infants exposed to an intravenous vitamin E product, E-Ferol.
In April 1984, the US FDA was notified of an unusual clinical syndrome consisting of ascites, liver and renal failure, thrombocytopenia, and death among low birth weight infants exposed to an intravenous vitamin E preparation, E-Ferol. The product, which had not been tested for safety prior to marketing, was voluntarily withdrawn from the market in early April. To further investigate the reported associations, the FDA conducted a retrospective cohort study among seven neonatal intensive care units where the product had been used. Standardized abstraction forms were completed for infants admitted to a unit between Nov 1, 1983, and April 30, 1984. Included in the study were 379 infants weighing 2,000 g or less and surviving at least two days; 148 (39%) had been exposed to E-Ferol. Compared with the unexposed infants, the exposed infants were more likely to die and to have ascites, hepatomegaly, thrombocytopenia, and a combination of clinical events similar to the syndrome initially reported. We conclude that the use of E-Ferol in these neonatal intensive care units was associated with increased morbidity and mortality among exposed infants.
Arrowsmith
J B
JB
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland.
Faich
G A
GA
Tomita
D K
DK
Kuritsky
J N
JN
Rosa
F W
FW
D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000401:mortality; D001201:Ascites; D006529:Hepatomegaly; D006801:Humans; D006932:Hyperbilirubinemia / Q000139:chemically induced* / Q000401:mortality; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D010288:Parenteral Nutrition; D012307:Risk Factors; D013577:Syndrome; D013921:Thrombocytopenia / Q000139:chemically induced* / Q000401:mortality; D013997:Time Factors; D024505:Tocopherols; D014810:Vitamin E / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D024502:alpha-Tocopherol / Q000031:analogs & derivatives*
D014810:Vitamin E; D024502:alpha-Tocopherol; D024505:Tocopherols