Simply Thick Warnings

This is the information posted by Suzanne Morris on the Dysphagia Mail List-Serv.  I just wanted to share this with everyone.

The FDA has just issued the following warning and caution about using the gum-based thickener, “Simply Thick” with premature infants under 37 weeks. Since this is the only type of thickener that can be used to thicken breast milk, it strongly suggests that this procedure should be discontinued and its use carefully reconsidered by therapists working with preemies who have swallowing difficulties.

SimplyThick: Public Health Notification – Risk of Life-Threatening Bowel
Condition

*AUDIENCE*: Consumers, Pediatrics, Emergency medicine

*ISSUE*: FDA notified parents, caregivers and health care providers not
to feed SimplyThick, a thickening agent for management of swallowing
disorders, to infants born before 37 weeks. The product may cause
necrotizing enterocolitis (NEC), a life-threatening condition
characterized by inflammation and death of intestinal tissue.

*BACKGROUND*: FDA first learned of adverse events possibly linked to the
product on May 13, 2011. To date, the agency is aware of 15 cases of
NEC, including two deaths, involving premature infants who were fed
SimplyThick for varying amounts of time. The product was mixed with
mothers’ breast milk or infant formula. Illnesses have been reported
from at least four different medical centers around the country. The
illnesses of which FDA is aware involve premature infants. SimplyThick
was added to the feeding regimen of those infants, who later developed
NEC, to help with swallowing difficulties stemming from complications of
premature birth.

The product is sold in packets of individual servings and in 64-ounce
dispenser bottles. The product can be purchased from distributors and
local pharmacies throughout the United States.

*RECOMMENDATION*: Health care providers should stop administering the
product to premature infants. Parents and caregivers who have questions
or concerns related to the use of the product and/or who have medical
concerns should contact their health care provider. See the photographs
at the link below for images of the product.

Read the MedWatch safety alert, including links to the Press Release and
product photos, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm

www.fda.gov

Feeding this product to infants may result in necrotizing enterocolitis, a life-threatening condition resulting in necrosis of intestinal tissue.

One thought on “Simply Thick Warnings

  1. On Tuesday July 12, 2011, I received a notice in the mail from Simply Thick (St. Louis, MO) that it was recalling all of its product with the letters “TP” included in the product code stamped on the edge of the packets. They instruct the recipient to destroy the product and then request that an enclosed postcard be completed with information regarding the fact that products with the “TP” nomenclature have indeed be destroyed. Evidently, there is more to it than just the fact that the product should not be used with premature infants. Something is wrong with the product produced between 6/01/2009 and 6/03/2011 at the Stone Mountain, GA good processing plant. The following web address is given for those who would like additional details about the recall: http://www.simplythick.com/recalladvisory

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