PEDIATRICS Vol. 78 No. 4 October 1986, pp. 591-600
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Illness With Fatalities in Premature Infants: Association With an Intravenous Vitamin E Preparation, E-Ferol

William J. Martone MD1, Walter W. Williams MD, MPH,1, Mary L. Mortensen MD1, Robert P. Gaynes MD1, John W. White PhD1, Vicien Lorch MD1, M. Dianne Murphy MD1, Sachchida N. Sinha MD1, Donald J. Frank MD1, Niki Kosmetatos MD1, Carl J. Bodenstein MD1, and Robert J. Roberts MD, PhD1

1 From the Center for Infectious Diseases and Center for Environmental Health, Centers for Disease Control, Atlanta; University of Tennessee Memorial Research Center and Hospital, Knoxville; Good Samaritan Hospital, Cincinnati; Sacred Heart/Deaconess Medical Centers, Spokane, Washington; and University of Iowa College of Medicine, Iowa City

Three clusters of an unusual syndrome in premature infants were investigated in three intensive care nurseries in 1984. A retrospective cohort study of 68 infants weighing le1,250 g at birth and surviving at least 72 hours revealed that in 13 infants ascites developed and in four at least two of the following abnormal laboratory values were found within a seven-day period: serum direct bilirubin ge2 mg/dL, blood urea nitrogen ge40 mg/dL or serum creatinine ge2 mg/dL, and platelet count le60,000/µL. All cases occurred after the introduction and use of intravenous E-Ferol, a vitamin E preparation that was new on the market when the clusters were reported. All 17 case infants but only 23 of 51 (45%) noncase infants received E-Ferol (P < .0001). Case and noncase infants were similar with respect to other complications and to receipt of medications and parenteral nutrition. A dose-response relationship was found; cases occurred in infants receiving E-Ferol dosages of > 20 U/kg/d. Case infants who had higher daily doses of E-Ferol had a shorter latency. No new cases were reported after use of E-Ferol was stopped. Results of these investigations led to a nationwide recall of intravenous E-Ferol.

Key Words: ascites • hepatotoxicity • vitamin E • polysorbate • E-Ferol

Submitted on October 3, 1985
Accepted on February 3, 1986