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AMERICAN ACADEMY of PEDIATRICS Benzyl Alcohol: Toxic

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AMERICAN ACADEMY of PEDIATRICS Benzyl Alcohol: Toxic N AMERICAN ACADEMY OF PEDIATRICS 0 Committee on Fetus and Newborn Committee on Drugs Benzyl Alcohol: Toxic Agent in Neonatal Units As advances have been made in the care of very and not to use diluents with this preservative to low-birth-weight infants, some techniques or prac- reconstitute or dilute medications for infants. tices have caused unexpected complications. One Metabolically, benzyl alcohol is oxidized to ben- such practice is umbilical vessel catheterization to zoic acid, conjugated with glycine in the liver, and monitor an infant’s arterial blood pressure, infuse excreted as hippuric acid. This metabolic pathway fluids and medications, and obtain blood specimens may not be functional in premature infants and for laboratory examinations. The catheters fre- may allow accumulation of benzoic acid (and per- quently are flushed with sterile isotonic saline or a haps unmetabolized benzyl alcohol) with resulting 5% solution of dextrose in water, with the flush metabolic acidosis and toxicity. Known toxic effects solution frequently being obtained from a multiple- on benzyl alcohol include respiratory failure, vaso- dose vial. The United States Pharmacopeia requires dilation, hypotension, convulsions, and paralysis; all medications or solutions marketed in a multiple- little is known specifically about toxicity of the dose vial to contain an antimicrobial preservative. compound in newborn infants. Most studies of ben- Benzyl alcohol, an aromatic alcohol, is used for this zyl alcohol toxicity in animals5 have evaluated a 0 purpose in a wide variety of medications and fluids single-rapid or slow infusion into adult animals of for parenteral therapy, usually in a concentration various species; none has evaluated multiple infu- of 0.9%. sions over a prolonged period into a newborn or Two groups of investigators, Gershanik et al’ immature animal. Thus, benzyl alcohol appears to (New Orleans) and Brown et al2 (Portland), inde- be a safe preservative for small-volume parenteral pendently concluded that an intravascular infusion medications for adults; data are not available to of flush solutions containing 0.9% benzyl alcohol justify the same conclusion for newborn infants. caused severe metabolic acidosis, encephalopathy, Pharmacologically, administration of preserved respiratory depression with gasping, and perhaps flush solutions to newborn infants and adults is other abnormalities leading to the death of a total considerably different. Infants receive a much of 16 infants. Blood and urine from several affected larger flush relative to body weight than do adults, infants had high levels of both benzoic and hippuric reducing considerably the therapeutic-toxic ratio acids, known metabolites of benzyl alcohol. Both for any substance infused. The increasingly aggres- groups stated that no additional cases occurred sive treatment of tiny newborn infants over the last after solutions with benzyl alcohol preservative several years may have contributed both to the were banned in their nurseries. occurrence of the problem and to its recent recog- Subsequently, in May 1982, the Food and Drug nition. In two studies,1’2 the volumes of flush solu- Administration3 with the concurrence of the Amer- tion received by the infants were estimated; and, ican Academy of Pediatrics and the Centers for from this, the amount of benzyl alcohol infused was Disease Control,4 urged pediatricians and other per- calculated. A daily administration of benzyl alcohol sonnel in hospitals not to use fluids preserved with approaching levels known to be toxic for a single benzyl alcohol (or other antimicrobial agents) as infusion in adult rats, the most sensitive of the intravascular flush solutions for newborn infants animals tested, was found.5 Unfortunately, the ac- tual amounts of benzyl alcohol received by the infants probably will remain unknown because pre- PEDIATRICS (ISSN 0031 4005). Copyright © 1983 by the cise information about the frequency and volume 0 American Academy of Pediatrics. of flush solutions administered is not recorded in 356 PEDIATRICS Vol. 72 No. 3 September 1983 Downloaded from www.aappublications.org/news by guest on October 2, 2021 most neonatal intensive care units. Without this carded when the new supply is received. Prepara- precise information, calculation of a dose-response tion of solutions, including addition of heparin if effect in the infants is not possible. this is used, should be carried out in the pharmacy. 0 The data reported by Gershanik et al’ and Brown Refrigeration will retard growth of most bacteria et a!2 are striking and warrant the action taken by that inadvertently contaminate the solutions dur- the FDA, even though both studies were uncon- ing preparation. Cold fluids should not be admin- trolled and the clinical information reported is not istered to infants; therefore, refrigerated solutions totally consistent. Preliminary data from other neo- will need to be brought to room temperature before natal units suggest that the mortality for small use. These flush solutions at room temperature premature infants (those weighing <1.1 kg) has should be used within a few hours or be discarded, declined after the preserved solutions were no a function that could coincide with the beginning longer used.6 These data must be confirmed. Addi- of each nursing shift. These alternative methods of tional laboratory and animal studies are needed to providing flush solutions have not been evaluated assess the significance and pathophysiology of the in clinical trials. problem,7 especially since benzyl alcohol continues Other sources of benzyl alcohol should be iden- to be administered to newborn infants in small tified in solutions and medications administered to amounts in a variety of medications. To define infants. Many medications also contain benzyl al- pathologic changes in different organ systems that cohol as a preservative. In general, the volume of might be attributable to benzyl alcohol poisoning, benzyl alcohol received by this route is negligible histologic studies of tissues from infants who died compared with the amount received in flush solu- after receiving solutions preserved with benzyl a!- tions. For newborn infants, it may be preferable to cohol should be conducted and the sections care- avoid use of medications with preservatives when- fully compared with specimens from matched in- ever possible. However, the presence of benzyl al- fants who died but had not received preserved so- cohol as a preservative should not proscribe use of lutions. medications indicated for treatment of an infant. The impact of eliminating benzyl alcohol as a Another potential source of exposure of infants to preservative in flush solutions for infants also re- benzyl alcohol is through instillation of an isotonic quires assessment. If the toxicity of the preserved solution into endotracheal tubes. Although pulmo- 0 solutions has been as great as the initial studies nary absorption of some pharmacologic agents is indicate, a significant decrease in mortality of small significant, information about absorption of benzyl premature infants should be observed. Conversely, alcohol by this route is unknown. if the preservatives have been important in pre- venting solution contamination, an increase in neo- COMMIVFEE ON FETUS AND NEWBORN, natal septicemia with selected organisms such 1982-1983 Pseudomonas, Kiebsielki, Enterobacter, and Serratia George A. Little, MD, Chairman may ensue. Rita G. Harper, MD As an emergency measure, manufacturers of com- Louis I. Levy, MD monly used solutions packaged in multiple-dose M. Jeffrey Maisels, MD vials with benzyl alcohol preservative have agreed Gerald Merenstein, MD with the FDA request to include a warning, “Not Ronald L. Poland, MD for Use in Newborns,” on the labels of these prod- Philip G. Rhodes, MD ucts. The FDA, USP, and others are reviewing the Philip Sunshine, MD need for permanent changes in products, labels, and package inserts. At the hospital level, each Liaison Representatives neonatal unit should assess its patterns and needs James R. Allen, MD, MPH in providing flush solutions for infants and should Gerard Ostheimer, MD establish a system with its hospital pharmacy to Fred Frigoletto, MD assure a satisfactory and safe means of providing Donald McNellis, MD sterile, unpreserved solutions. Vials of normal sa- Dennis Hey, DO line and 5% dextrose solution are available without V. Robert Kelley, MD preservatives, although by USP standard these are Eugene Outerbridge, MD labeled for single use only. Alternatively, unit-dose flushes in syringes or a single, large-volume con- AAP Section Liaisons tamer of a flush solution could be dispensed several George J. Peckham, MD 0 times each day to the nursery area; unused syringes Paula Brill, MD or fluid remaining in the container should be dis- Alfred A. deLorimier, MD AMERICAN ACADEMY OF PEDIATRICS 357 Downloaded from www.aappublications.org/news by guest on October 2, 2021 COMMITTEE ON DRUGS, 1982-1983 AAP Section Liaisons Albert W. Pruitt, MD, Chairman Earl J. Brewer, MD Walter R. Anyan, Jr, MD John A. Leer, MD Reba M. Hill, MD 0 REFERENCES Ralph E. Kauffman, MD Howard C. Mofenson, MD 1. Gershanik J, Boecler B, Ensley H, et al: The gasping syn- drome and benzyl alcohol poisoning. N Engi J Med Harvey S. Singer, MD 1982;307:1384 Stephen P. Spielberg, MD, PhD 2. Brown WJ, Buist NRM, Gipson HTC, et al: Fatal benzyl alcohol poisoning in a neonatal intensive care unit. Lancet 1982;1:1250 3. Food and Drug Administration Bulletin, Dept of Health and Human Services, May 28, 1982 Liaison Representatives 4. Centers for Disease Control: Neonatal deaths associated John C. Ballin, MD with use of benzyl alcohol-United States. MMWR 1982;31:290 Louis Farchione, MD 5. Kimura ET, Darby TD, Krause RA, et al: Parenteral toxicity Martha M. Freeman, MD studies with benzyl alcohol. Toxicol Appi Pharmacol Sam A. Licata, MD 1971;18:6O 6. Hiller JL, DeVito VJ, Allen JR, et al: Decreased mortality Jennifer Niebyl, MD in very-low-birth-weight (VLBW) infants following discon- Godfrey Oakley, MD tinuation of intravascular flush solutions containing benzyl Steven Sawchuk, MD alcohol.
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