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CDC report on Portagen

This article was originally published in The Tan Sheet

Executive Summary

"Clinicians should be aware that powdered [infant] formulas are not sterile products and might contain opportunistic bacterial pathogens," CDC says in April 12 Morbidity & Mortality Weekly Report summarizing premature infant's April 2001 death from meningitis caused by Enterobacter sakazakii. Infant became ill after being tube-fed Portagen, Mead Johnson's nutritional powder for infants who cannot digest or absorb fats. BMS division announced recall of Portagen batch at issue March 29; product is intended for use under doctor's supervision and is not typically sold at retail. In a letter to healthcare professionals April 12, FDA says "several outbreaks" of the infection in neonatal intensive care units worldwide have been associated with milk-based powdered infant formulas. Agency recommends powdered formulas "not be used in neonatal intensive care settings unless there is no alternative available"...

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Health Canada infant formula

"Whenever possible, an alternative to powdered formulas, such as ready-to-feed and concentrated liquid formulas, should be chosen in the [Neonatal Intensive Care Unit] setting," a Health Canada advisory recommends. The Sept. 26 action responds to incidence of worldwide Enterobacter sakazakii infection in hospitals resulting from milk-based, powdered infant formulas, which "are not commercially sterile products." When powdered formula must be used, Health Canada suggests they be safely prepared by trained personnel using sterilized water, adding "proper sanitation should be adhered to at all times." FDA issued a similar alert in April (1"The Tan Sheet" April 15, 2002, In Brief)...

Powdered formula contamination

Methods to validate that milk-based powdered infant formulas do not contain the pathogen Enterobacter sakazakii posted on 1CFSAN Web site. Directions, required equipment and materials, media and reagents are referenced in guidelines. In late March, Mead Johnson announced recall of Portagen powdered formula due to possible contamination (2"The Tan Sheet" April 15, 2002, In Brief)...

QUOTED. 30 March 2020. Stephen Hahn.

President Trump on 27 March signed into law a $2.2tn COVID-19 stimulus package that provides $80m to the US Food and Drug Administration for emergency use authorization of medical products. See what FDA commissioner Stephen Hahn said about it here.





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