Aluminum contamination in parenteral products

In 1986, the US Food and Drug Administration issued an aluminum mandate in hopes of minimizing patient exposure to aluminum contaminates contained in parenteral nutrition additives. The purpose of this article is to revisit the status of aluminum contamination as it relates to parenteral nutrition and to survey the recent literature to determine if any new findings have emerged. A special emphasis will be placed on the complications associated with aluminum toxicity.

In addition to metabolic bone disease, patients with aluminum toxicity are also prone to other complications such as neurodevelopmental delays and cholestasis. Other potentially serious consequences, including osteoporosis, growth failure, and dementia, can arise years after the initial exposure to aluminum, showing that preventing toxicity is imperative.

Unlike the rapid response to eliminating aluminum toxicity in the dialysis patient population, similar successes have not been realized in patients receiving parenteral nutrition solutions. Product formulation changes have been slow to emerge from manufacturers. It remains the responsibility of healthcare practitioners to recognize the patient populations at risk for toxicity and act accordingly. Monitoring aluminum status and purchasing products known to possess the least amount of aluminum are two such approaches.