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Executive Summary

ANTIMICROBIAL PRESERVATIVE RESTRICTED USE IN SINGLE-DOSE PARENTERALS is under consideration by FDA, the agency announced in a May 15 Federal Register notice. FDA said it is "considering whether to propose to prohibit the use of benzyl alcohol in single-dose products, such as heparin solutions, which are frequently administered to newborn infants," or whether "to propose to prohibit the use of any antimicrobial preservative in single-dose containers of parenteral products frequently administered to newborn infants." With respect to the use of preservatives in multiple-dose parenteral products, FDA said it is considering requiring a label warning for either all such products, or for those products containing benzyl alcohol which are frequently administered to newborn infants, or for all multiple-dose parenterals containing any antimicrobial preservative which are frequently administered to newborns. "The warning would state that caution should be used in the administration of these drugs to newborn infants and individuals with impaired liver function," FDA said. The agency explained that it was considering such actions "because of reports linking the use of parenteral drug products containing an antimicrobial preservative, particularly bacteriostatic water for injection and bacteriostatic sodium chloride injection preserved with benzyl alcohol, to morbidity and mortality among low-weight newborn infants." FDA said the syndrome, which is "possibly linked" to the products, "is characterized by central nervous system depression, metabolic acidosis, and gasping respirations" and can "lead to serious renal and other system failures, hypotension, and less frequently, to intracranial hemorrhage and death." The agency noted that it is theorized "that the immature liver of the low-weight, premature infant is incapable of properly metabolizing and excreting benzyl alcohol and its metabolites." In requesting comments on the possible agency proposals, FDA also requested information "concerning the need for a general warning statement or other actions applicable to parenteral drug products containing any substance that could be considered a preservative intended for newborn infants, other special patient populations, or for all patients." For instance, FDA said such additives as antioxidants and stabilizers, while generally considered nontoxic, have been associated with toxicity reports from time to time.

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