A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market

Abstract

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) started an intensive review of commercially available parenteral vitamin and trace element (TE) products in 2009. The chief findings were that adult multi-TE products currently available in the United States (U.S.) provide potentially toxic amounts of manganese, copper, and chromium, and neonatal/pediatric multi-TE products provide potentially toxic amounts of manganese and chromium. The multivitamin products appeared safe and effective; however, a separate parenteral vitamin D product is needed for those patients on standard therapy who continue to be vitamin D depleted and are unresponsive to oral supplements. The review process also extended to parenteral choline and carnitine. Although choline and carnitine are not technically vitamins or trace elements, choline is an essential nutrient in all age groups, and carnitine is an essential nutrient in infants, according to the Food and Nutrition Board of the Institute of Medicine. A parenteral choline product needs to be developed and available. Efforts are currently under way to engage the U.S. Food and Drug Administration (FDA) and the parenteral nutrient industry so A.S.P.E.N.'s recommendations can become a commercial reality.

Trace Elements in Parenteral Nutrition: Considerations for the Prescribing Clinician

“…Iodine is needed for thyroid function but it is not routinely supplemented in the US [5]. It is included in many multi-TE products in Europe, Australia, and Canada [6,69,70].…”

“…Iron deficiency is common in HPN patients [72], but iron is not routinely available in North America in PN formulations for several reasons, including concerns with stability in fat emulsion [5]. It is available for the addition in PN in other markets.…”

“…Conversely, in conditions of organ dysfunction, certain reductions in trace elements are recommended [4]. Despite expert agreement that copper, manganese, and chromium doses be reduced, the FDA has not updated the 1979 guidelines [2,5]. There are currently a variety of pre-mixed multi-TE combinations that are commercially available for addition to parenteral nutrition (PN) solutions.…”

“…There are currently a variety of pre-mixed multi-TE combinations that are commercially available for addition to parenteral nutrition (PN) solutions. Many of these still contain doses of TEs that are not in keeping with the current recommendations from expert groups [5,6]. The following is a review of TEs that are currently supplemented in PN, and a brief review on TEs that are not routinely added in North America but whose importance should not be overlooked.…”

Optimizing Vitamin and Trace Element Profiles in Blood after Gastrointestinal Tract Surgery by a New Parenteral Nutrition Formula

“…The new formula can be expected to improve the quality of nutritional therapy. AMA1975 formula is still used not only in Japan but also in other countries [26]. The results of the present study may lead to a change in PN formulas used in many countries and areas.…”