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Update on use of "Simply Thick" for infants

Starting date:
October 18, 2012
Posting date:
October 18, 2012
Type of communication:
Information Update
Subcategory:
Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Identification number:
RA-15074

Health Canada is advising parents and caregivers to consult their health professional before using Simply Thick to feed infants. This updates previous advice that focused on the use of this product for premature infants.

Simply Thick is a xanthan gum-based product marketed for the management of swallowing disorders. It can be added to thicken liquids, such as breast milk and infant formula, to make them easier to swallow.

Health Canada's 2011 advisory was based on concerns that the use of Simply Thick for premature infants might be related to several cases reported in the United States of necrotizing enterocolitis (NEC). Necrotizing enterocolitis mostly affects premature infants and is considered a serious and potentially life-threatening condition where the tissue of the intestine is damaged.

In August 2012, the United States Food and Drug Administration (FDA) published its analysis of 22 identified cases of NEC associated with its May 2011 Simply Thick advisory. One of the cases involved a full-term infant that was fed using Simply Thick. As a result, the FDA has updated its advisory to indicate that infants of any age using this product may face increased risk of NEC.

The Public Health Agency of Canada, in partnership with the Canadian Paediatric Surveillance Program, undertook a survey of physicians in Canada following Health Canada's 2011 advisory. Two cases of NEC in infants following the use of Simply Thick were reported, one of which was a premature infant.

Further study is needed to determine if there is an actual link between consumption of Simply Thick and the development of NEC. However, parents and health professionals should be aware of the potential risk before deciding whether to use Simply Thick to aid in feeding infants of any age. Health Canada is urging parents and caregivers to work with their health care professionals to determine whether the use of Simply Thick is appropriate for their infant.

Health Canada and the Public Health Agency of Canada are working to share this information with health professionals in order to support them in advising parents on the use of Simply Thick.

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