FROM THE EDITOR: FDA Effective Date for Aluminum Labeling Approaching
Carol Rollins, MS, RD, PharmD, BCNSP
Coordinator, Nutrition Support Service/Clinical
Pharmacist for Home Infusion, Arizona Health
Sciences Center, Tucson, Arizona
The effective date of the Food and Drug Administration (FDA) rule concerning the federal labeling requirements for aluminum content in large-volume parenterals (LVPs), small-volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN) is January 26, 2003.1,2,3 The concerns and potential harm that can occur from excessive aluminum exposure are discussed in Dr. Klein's article presented here.
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ALUMINUM TOXICITY AND ITS CONTROL IN PATIENTS RECEIVING TOTAL PARENTERAL NUTRITION
Guest editor:
Gordon L. Klein, MD, MPH
Professor of Pediatrics and Preventive Medicine
University of Texas Medical Branch
Galveston, Texas
On January 26, 2001, the new FDA rule was to take effect concerning aluminum contamination of parenterals and injectables used for total parenteral nutrition (TPN). The rule, published 1 year previously in the Federal Register,1states that all large-volume parenterals, such as dextrose and water solutions, saline solutions, and crystalline amino acids, must contain no more than 25 µg/L of aluminum.
[FULL STORY]
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CASE STUDY
Aluminum toxicity in dialysis patient receiving TPN
The following case illustrates the encephalopathy, bone disease, and anemia that have been associated with aluminum toxicity in dialysis patients who are receiving aluminum-contaminated parenteral products and aluminum-containing phosphate binders. Regulations requiring aluminum content data on parenteral product labels were spurred by reports of aluminum toxicity in dialysis patients and neonates.
[FULL STORY]
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