Aluminum content of parenteral nutrition in neonates: measured versus calculated levels.
OBJECTIVE
Aluminum (Al) is associated with significant central nervous system toxicity and bone and liver damage. Because Al is a contaminant of parenteral nutrition (PN) components including calcium and phosphate additives, premature infants are at potentially high risk for toxicity. The US Food and Drug Administration (FDA) has mandated PN component product labeling and recommended maximum Al daily exposure limits. The objective of this article is to determine the actual Al content of neonatal PN solutions, compare these values to the calculated amounts from manufacturers' PN product labels, and ascertain whether the actual Al exposure exceeds the FDA recommended maximum of 5 microg . kg(-1) . day(-1).


METHODS
Samples from 40 neonatal patient PN solutions were selected for sampling and Al content determination. Samples were also taken from 16 manufacturer's component products used in PN formulation. All of the samples were sent to Mayo Laboratories for Al content measurement. The calculated Al concentrations in PN samples were determined from the manufacturer's labeled content.


RESULTS
Both measured and calculated Al concentrations exceeded the FDA recommended safe limit of <5 microg . kg(-1) . day(-1). The actual measured Al content was significantly lower than the calculated Al content in both the patient PN solutions and the component product samples.


CONCLUSIONS
Al exposure exceeded the FDA recommended maximum limit for all patient samples; however, the actual measured Al content of all the samples was significantly less than the calculated Al content based on manufacturer's labels. These findings suggest that manufacturers label their products with actual Al content at the time of product release rather than at time of expiration. Periodic monitoring of Al levels should be considered with prolonged PN therapy. Changes in manufacturing processes, including the use of better raw materials, are essential to reduce Al contamination to meet FDA mandates.
Poole
Robert L
RL
Department of Pharmacy, Lucile Packard Children's Hospital, Stanford University School of Medicine, 725 Welch Road, Palo Alto, CA 94304, USA. rpoole@lpch.org
Schiff
Linda
L
Hintz
Susan R
SR
Wong
Allison
A
Mackenzie
Nicol
N
Kerner
John A
JA
D000535:Aluminum / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis*; D003257:Consumer Product Safety; D005506:Food Contamination / Q000032:analysis*; D005515:Food Labeling / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D007234:Infant, Premature; D010288:Parenteral Nutrition; D014481:United States; D014486:United States Food and Drug Administration
D000535:Aluminum