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A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market.
Vanek, Vincent W; Borum, Peggy; Buchman, Alan; Fessler, Theresa A; Howard, Lyn; Shenkin, Alan; Valentine, Christina J.
Affiliation
  • Vanek VW; Mercy Health, Youngstown, Ohio vince_vanek@mercy.com.
  • Borum P; University of Florida, Gainesville, Florida.
  • Buchman A; Northwestern University School of Medicine, Chicago, Illinois.
  • Fessler TA; University of Virginia, Charlottesville, Virginia.
  • Howard L; Albany Medical College, Albany, New York (Retired).
  • Shenkin A; Royal Liverpool University Hospital, Liverpool, United Kingdom.
  • Valentine CJ; Mead Johnson Nutrition.
Nutr Clin Pract ; 30(4): 559-69, 2015 Aug.
Article in En | MEDLINE | ID: mdl-26113560
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Parenteral Nutrition / Micronutrients / Dietary Supplements Type of study: Guideline Limits: Adult / Humans / Infant Country/Region as subject: America do norte Language: En Journal: Nutr Clin Pract Journal subject: CIENCIAS DA NUTRICAO / ENFERMAGEM Year: 2015 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Parenteral Nutrition / Micronutrients / Dietary Supplements Type of study: Guideline Limits: Adult / Humans / Infant Country/Region as subject: America do norte Language: En Journal: Nutr Clin Pract Journal subject: CIENCIAS DA NUTRICAO / ENFERMAGEM Year: 2015 Document type: Article