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Illness with fatalities in premature infants: association with an intravenous vitamin E preparation, E-Ferol
Insights
Intravenous vitamin E (E-Ferol) was linked to a serious syndrome in premature infants, causing ascites and abnormal lab values. Stopping E-Ferol use halted new cases, leading to its recall.
Area of Science:
- Neonatal Medicine
- Clinical Toxicology
- Pediatric Pharmacology
Background:
- An unusual syndrome emerged in premature infants across three NICUs in 1984.
- The syndrome presented with ascites and significant laboratory abnormalities.
Purpose of the Study:
- To investigate the cause of a newly observed syndrome in premature infants.
- To determine the association between the syndrome and the use of intravenous E-Ferol.
Main Methods:
- A retrospective cohort study of 68 premature infants (birth weight ≤ 1,250 g) was conducted.
- Infants were assessed for ascites and specific abnormal laboratory values (bilirubin, BUN, creatinine, platelets).
- E-Ferol exposure and dosage were compared between case and non-case infants.
Main Results:
- Thirteen infants developed ascites, and four had multiple abnormal lab values.
- All 17 affected infants had received intravenous E-Ferol, compared to 45% of controls (P < .0001).
- A dose-response relationship was observed, with higher E-Ferol doses (> 20 U/kg/d) linked to increased risk and shorter latency.
Conclusions:
- Intravenous E-Ferol was strongly associated with the observed syndrome in premature infants.
- The findings led to a nationwide recall of intravenous E-Ferol.
- This highlights the importance of post-marketing surveillance for new pharmaceutical products.
Abstract:
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.