Health Canada infant formula
This article was originally published in The Tan Sheet
Executive Summary
"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)...
You may also be interested in...
CDC report on Portagen
"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"...
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.