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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.
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
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
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.