Parenteral drug products containing aluminum as an ingredient or a contaminant: response to FDA notice of intent

Article Abstract:

Aluminum, like many other metallic elements, may be required by the body in small (trace) amounts for proper tissue function. However, accumulation of these metals, due either to defective excretion or increased ingestion, can have severely toxic effects. Normally functioning kidneys can handle the small amounts of aluminum present in normal foodstuffs. However, patients with kidney disease and those who receive total parenteral nutrition (TPN; simple nutrients given intravenously to fulfill total dietary needs) have developed bone disease associated with tissue accumulation of aluminum. In addition, patients with uremia (excess nitrogen in the blood due to kidney failure) have developed brain dysfunction involving dementia. Bone accumulation of aluminum and altered calcium deposition in bone have also been found in premature infants, who have reduced kidney function, that have been treated with TPN. Aluminum accumulation in TPN-treated patients has been ascribed to contamination of TPN solutions, which in the past were made from casein (milk protein). Purified amino acids (the building blocks of proteins) rather than casein are now used for adults, but aluminum contamination still occurs in TPN solutions for premature infants, chiefly due to supplements containing calcium and phosphate salts, albumin (a standard blood-derived protein), and heparin. Aluminum accumulation in patients with kidney disease derives not only from decreased kidney function, but former use of nondeionized water, from which salts were not removed. Deionized water is now used for dialysis, and the major source of exposure for these patients is now aluminum-containing antacids and particular aluminum-containing phosphate-binding gels. This article provides a commentary to a notice of intent to regulate aluminum content in TPN solutions and other sources, published by the Food and Drug Administration (FDA). Additional considerations and further recommendations are discussed. (Consumer Summary produced by Reliance Medical Information, Inc.)

Complications and side effects, Diseases, Infants (Premature), Premature infants, Composition, Aluminum, Aluminum (Metal), Kidney diseases

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Ascorbic acid: effect on ongoing iron absorption and status in iron-depleted young women

Article Abstract:

Iron absorption is enhanced by consuming vitamin C at the same meal. More specifically, iron in foods other than meats, also called nonheme iron, is better absorbed in the presence of vitamin C, while heme iron, found in meats, is not affected in this way. It is particularly important to improve iron absorption in young, premenopausal women because it is difficult for them to meet their daily iron needs from diet alone without an iron supplement. Because women generally do not eat as much food as men, and often consume less meat, they obtain less iron from the diet. However, due to menstrual blood loss and the iron requirements of pregnancy and lactation, the iron needs of young women are significantly greater than those of men. A study was performed to investigate the effects of vitamin C on iron absorption in 11 premenopausal women. The iron stores of the women were first depleted by following a low iron diet for two to three months and by taking blood samples, which removed iron from the body. The women then consumed a diet supplying 13.7 milligrams (mg) of iron in 2,000 calories per day for 5.5 weeks; this is less than the Recommended Dietary Allowance for women. Subjects also took either an inert placebo or a 500 mg vitamin C tablet at each meal (1,500 mg daily). Iron absorption was greater in the vitamin C-supplemented group, who absorbed an average of 38 percent of the iron consumed, than in the placebo group, who absorbed 27 percent of the iron ingested. Thus, in iron-depleted premenopausal women, vitamin C supplementation improved iron absorption. (Consumer Summary produced by Reliance Medical Information, Inc.)

Women, Physiological aspects, Food, Food and nutrition, Diet therapy, Vitamin C, Iron deficiency anemia, Vitamin C in human nutrition

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Selected ultratrace elements in total parenteral nutrition solutions

Article Abstract:

Total parenteral nutrition (TPN) is a method of providing the complete nutritional needs of patients by intravenous feeding. It is used for persons who cannot eat or be fed by a tube into the digestive tract (tube feeding). While TPN may be used for a short time after surgery or to aid in recovery from a serious illness or accident, some individuals require TPN indefinitely and the equipment can now be set up in the home. Since patients on long-term TPN rely exclusively on this form of nutrition, the TPN solution must contain all nutrients needed by the human body, even nutrients that are only required in tiny amounts (trace elements). Trace elements are routinely included in TPN, but ultratrace elements are not intentionally added although they may appear as contaminants. While ultratrace elements such as boron, molybdenum, nickel and vanadium may be essential, others such as aluminum and cadmium are toxic if too much is infused by TPN. Standard TPN solutions were analyzed to measure the exact amounts of ultratrace elements present as contaminants. Contamination was found to be common and the levels of contaminants varied. The amounts of certain ultratrace elements measured were comparable to amounts consumed from food, which appeared to be safe, but aluminum in TPN was higher and boron lower than levels typically derived from the diet. Aluminum must be minimized in TPN solutions; toxicity symptoms include dementia and bone disorders. More research is needed to assess the impact of ultratrace element contamination on long-term TPN patients.

Research, Analysis, Minerals (Nutrients), Artificial feeding, Feeding methods, Trace elements in nutrition, Micronutrients, Minerals in human nutrition

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