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

Article · December 1982with102 Reads
Source: PubMed
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. The 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. While further studies are being carried out to confirm and clarify the mechanism of toxicity of benzyl alcohol, it is prudent for pediatricians to discontinue the use of solutions that contain benzyl alcohol to flush IV catheters in premature infants. Sterile sodium chloride for injection (not bacteriostatic sodium chloride) should be used instead. Furthermore, reports of possible or definite toxic effects associated with benzyl alcohol should be reported to the FDA. While these solutions have been used in adults for decades with apparent impunity, the present experience serves to reinforce the fact that children and neonates are clearly different than adults as it relates to the handling of drugs.