PEDIATRICS Vol. 72 No. 3 September 1983, pp. 356-358
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Benzyl Alcohol: Toxic Agent in Neonatal Units

Committee on Fetus and Newborn and Committee on Drugs

As advances have been made in the care of very low-birth-weight infants, some techniques or practices have caused unexpected complications. One such practice is umbilical vessel catheterization to monitor an infant's arterial blood pressure, infuse fluids and medications, and obtain blood specimens for laboratory examinations. The catheters frequently are flushed with sterile isotonic saline or a 5% solution of dextrose in water, with the flush solution frequently being obtained from a multiple-dose vial. The United States Pharmacopeia requires all medications or solutions marketed in a multiple-dose vial to contain an antimicrobial preservative. Benzyl alcohol, an aromatic alcohol, is used for this purpose in a wide variety of medications and fluids for parenteral therapy, usually in a concentration of 0.9%.

Two groups of investigators, Gershanik et al1 (New Orleans) and Brown et al2 (Portland), independently concluded that an intravascular infusion of flush solutions containing 0.9% benzyl alcohol caused severe metabolic acidosis, encephalopathy, respiratory depression with gasping, and perhaps other abnormalities leading to the death of a total of 16 infants. Blood and urine from several affected infants had high levels of both benzoic and hippuric acids, known metabolites of benzyl alcohol. Both groups stated that no additional cases occurred after solutions with benzyl alcohol preservative were banned in their nurseries.

Subsequently, in May 1982, the Food and Drug Administration3 with the concurrence of the American Academy of Pediatrics and the Centers for Disease Control,4 urged pediatricians and other personnel in hospitals not to use fluids preserved with benzyl alcohol (or other antimicrobial agents) as intravascular flush solutions for newborn infants and not to use diluents with this preservative to reconstitute or dilute medications for infants.




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