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Formula Thickening Agents Alert for PWS

The following was on the web:

Health Canada is strongly advising Canadians to speak to their healthcare practitioner with any questions or concerns regarding "Simply Thick" if this product is being used.

"Simply Thick" is a product that can be added to liquids, such as breast milk and infant formula, to thicken them to make them easier to swallow. It is sometimes used for premature infants to help with swallowing difficulties.

The US FDA has reported 15 cases of necrotizing enterocolitis (NEC) including two deaths, involving infants who were fed "Simply Thick" for varying amounts of time. NEC is a serious and sometimes fatal condition where the tissue of the intestine is damaged. It mostly affects premature newborn infants.

A response on this issue from Norma Terrazas, the registered dietician on our PWSA (USA) Clinical Advisory Board was:   

They should contact their healthcare provider if they are on a thickening agent and their child is < (less than) 3 months corrected gestational age. 

Below are some guidelines instituted here at Texas Children’s Hospital.  I am sure every major hospital institution will have some guidelines also made available to their staff. 

  1. External thickening agents, including Simply Thick, Thick It, and several other similar products should not be used under any circumstances for any infants < 44 week postmenstrual age *(gestational age plus chronological age). At present the cases of NEC and similar illnesses are limited to those born < 37 weeks who developed illness at < 43 weeks PMA. This puts a small boundary around it.
  2. It is not recommended to use these products for any infants < 3 months corrected age to provide a further safety margin while the investigation is underway and cases collected.
  3. Alternative thickening approaches including rice cereal are not recommended as they are nutritionally inadequate, do not often work with human milk and have little if any evidence of efficacy in our patient population. However, in an individual circumstance, on a risk:benefit consideration in which no alternative was deemed available, a practitioner could use rice cereal for a formula-fed infant. We do not believe this is the correct solution however to any feeding related problem in newborns.
  4. Use of specialized anti-reflux infant formulas is also not recommended for our preterm infant population, although these formulas are probably safe and can be considered in special circumstances. Again, we do not believe this is the correct solution to feeding related problems, especially in preterm infants.
  5.  Any infant discharged in the last 4 weeks on any thickening agents who was born at < 37 weeks gestation should immediately have the product stopped.

 * Postmenstrual age is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age). Postmenstrual age is usually described in number of weeks and is most frequently applied during the perinatal period beginning after the day of birth. Therefore, a preterm infant born at a gestational age of 33 weeks who is currently 10 weeks old (chronological age) would have a postmenstrual age of 43 weeks.

edited: 02/09/2012

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