Illness with fatalities in premature infants: association with an intravenous vitamin E preparation, E-Ferol.

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 less than or equal to 1,250 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 greater than or equal to 2 mg/dL, blood urea nitrogen greater than or equal to 40 mg/dL or serum creatinine greater than or equal to 2 mg/dL, and platelet count less than or equal to 60,000/microL. 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 less than .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 greater than 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.