Fatal benzyl alcohol poisoning in neonatal intensive care units. A new concern for pediatricians.

Abstract

In May 1982, the Food and Drug Administration urged hospitals and pediatricians to discontinue the use of intravenous (IV) infusions of saline solution containing benzyl alcohol, as well as medications containing benzyl alcohol as a preservative, in premature infants. More than 50,000 letters were mailed to pediatricians, hospital pharmacists, and hospital administrators notifying them of the problem.1The FDA based its recommendation on the results of two studies that suggested that benzyl alcohol, used as a preservative in small multiple-dose vials of sodium chloride solution or water for injection, had caused a fatal toxic syndrome in premature infants. The suspicion that a benzyl alcohol preservative was associated with these neonatal deaths was first raised by Gershanik and associates2from the Southern Baptist Hospital, New Orleans, at the January 1982 meeting of the Southern Society for Pediatric Research. Gershanik and his associates described five neonates during a 16-month period