“Simply Thick” May Be Linked to Illnesses in Premature Infants in the U.S.

Starting date:

May 20, 2011

Posting date:

May 20, 2011

Type of communication:

Advisory

Subcategory:

Drugs, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals, General Public

Identification number:

RA-110005075

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Following a release issued by the United States Food and Drug Administration (FDA), Health Canada and the Public Health Agency of Canada are advising parents, caregivers and healthcare providers not to feed "Simply Thick" to premature infants.

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.

The Government of Canada is working with the FDA on this issue and is investigating whether there have been any related cases in Canada. However, at this early stage in our investigation, we are not aware of similar illnesses in Canada linked to this product.

The Canadian Food Inspection Agency has confirmed that the product is available in Canada and is working with Canadian suppliers to communicate this information to their customers.

As more information becomes available as part of this investigation, we will continue to update Canadians.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709