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Aluminum Exposure From Pediatric Parenteral Nutrition: Meeting the New FDA Regulation

From ¹ Lucile Packard Children's Hospital at Stanford, ² Stanford University School of Medicine, Stanford, California, and ³ Monterey Medical Solutions, Inc, Salinas, California.

Address correspondence to: Robert L. Poole, PharmD, Lucile Packard Children's Hospital at Stanford, Pharmacy Department, 725 Welch Road, Palo Alto, CA 94087; e-mail: rpoole{at}lpch.org.

Background: Aluminum toxicity can cause serious central nervous system and bone toxicities. Aluminum is a contaminant of parenteral nutrition (PN) solution components. Premature neonates requiring high doses of calcium and phosphate to mineralize their bones, children with impaired renal function, and children on PN therapy for prolonged duration are at the highest risk. Effective in July 2004, the U.S. Food and Drug Administration (FDA) mandated labeling requirements for aluminum content in all PN solution components. To assess the aluminum exposure in neonatal and pediatric populations, this study aims to determine patients' daily aluminum load (µg/kg/d) delivered from PN solutions. Methods: The study included all inpatients who received PN during calendar year 2006 (13,384 PN patient days). The calculated parameters of µg/kg/d and µg/L of parentally administered aluminum were stratified according to patient age and weight. Aluminum content by product and manufacturer were tabulated. Results: Forty-nine percent of the PN patient days were in patients weighing < 3 kg. These patients also received the largest amounts of aluminum (range, 30-60 µg/kg/d). Meeting the FDA regulation was possible only in patients weighing > 50 kg. Conclusions: Currently available parenteral products used to make PN solutions contain amounts of aluminum that make it impossible to meet the new FDA rule of <5 µg/kg/d of aluminum exposure. Manufacturers must identify, develop, and adopt new methods to reduce the aluminum contamination in their products. Health care professionals should calculate aluminum loads in patients and make informed decisions when choosing PN products.

Key Words: parenteral nutrition • pediatric • aluminum • toxicity • FDA regulation