This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Search for Related Content PubMed PubMed Citation Social Bookmarking                         What's this?

Parenteral Drug Products Containing Aluminum as an Ingredient or a Contaminant: Response to Food and Drug Administration Notice of Intent and Request for Information

Aluminum remains a significant contaminant of total parenteral nutrition (TPN) solutions and may be elevated in bone, urine, and plasma of infants receiving TPN. Aluminum accumulation in tissues of uremic patients and adult TPN patients has been associated with low-turnover bone disease. Furthermore, aluminum has also been linked with encephalopathy and anemia in uremic patients and with hepatic cholestasis in experimental animals. Because of the toxic effects of aluminum, the Food and Drug Administration (FDA) recently published a notice of intent to set an upper limit of 25 µg/L for aluminum in large-volume parenterals and to require manufacturers of small-volume parenterals, such as calcium and phosphate salts, to measure aluminum content and note this content on the package label. The ASCN/A.S.P.E.N. Working Group on Standards for Aluminum Content of Parenteral Nutrition Solutions supports these intentions and further urges the FDA to require that cumulative aluminum intake in terms of safe, unsafe, and toxic quantities of aluminum per kilogram be made known to physicians and pharmacists preparing the TPN solutions, to ensure that manufacturers use appropriate control procedures in aluminum measurements, and to employ a standard unit of aluminum measurement. (Journal of Parenteral and Enteral Nutrition 15:194-198, 1991)

Journal of Parenteral and Enteral Nutrition, Vol. 15, No. 2, 194-198 (1991)
DOI: 10.1177/0148607191015002194


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				B. S. Smith, H. Kothari, B. D. Hayes, G. Tataronis, M. Hudlin, J. Doole, and C. Hartman Effect of additive selection on calculated aluminum content of parenteral nutrient solutions Am. J. Health Syst. Pharm., April 1, 2007; 64(7): 730 - 739. [Abstract] [Full Text] [PDF]

				A. Davis, R. Spillane, and L. Zublena Teaching Case; Aluminum: A Problem Trace Metal in Nutrition Support Nutr Clin Pract, October 1, 1999; 14(5): 227 - 231. [Abstract] [PDF]

				J. F. Mouser and G. S. Sacks Vitamin D and Minerals: How Much for Preterm Infants During a Multivitamin Shortage? Nutr Clin Pract, April 1, 1999; 14(2): 51 - 57. [Abstract] [PDF]

				W. W.K. Koo and R. W. Chesney Special Report From ASCN/ A.S.P.E.N. Working Group on Standards for Aluminum Content of Parenteral Nutrition Solutions JPEN J Parenter Enteral Nutr, January 1, 1992; 16(1): 92 - 93. [PDF]