title: Aluminum contamination in products used in parenteral nutrition: has anything changed?
abstract: In July 2004, the U.S. Food and Drug Administration issued a mandate that required manufacturers to include the aluminum content on the labels of the additives commonly used in the compounding of parenteral nutrition solutions. It was the hope that practitioners would use this information to minimize the amount of aluminum exposure provided by parenteral nutrition to less than the 5 mCg/kg/d, the threshold deemed as "safe." Since that time, it has been difficult to easily incorporate these guidelines into clinical practice due to limitations in current product formulations. The purpose of this article is to revisit the rationale for the development of this mandate and to survey the literature since its implementation to determine if any new findings have emerged. A brief overview of aluminum toxicity, the patient populations at risk, treatment options, and compounding considerations is also presented.
authors.affiliation: Department of Pharmacy, Division of Gastroenterology/Nutrition, Children's Hospital, Boston, Massachusetts, USA. kathleen.gura@childrens.harvard.edu
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Gura
mesh_terms: D000535:Aluminum / Q000633:toxicity*; D004781:Environmental Exposure / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D005506:Food Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D005526:Food, Formulated / Q000592:standards / Q000633:toxicity*; D006801:Humans; D008452:Maximum Allowable Concentration; D010288:Parenteral Nutrition / Q000009:adverse effects*; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000535:Aluminum