FDA: Do Not Feed SimplyThick to Premature Infants

[Missouriwatcher]

The thickening product may cause necrotizing enterocolitis (NEC), a life-threatening condition

Fast Facts
FDA is warning 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.
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...

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 products.

Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. 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 current situation is unusual because NEC most often occurs in babies within the hospital early in their premature course. But among the ill babies of which FDA is aware, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.

What are the Symptoms of Illness/Injury?
NEC is a life-threatening condition characterized by inflammation and death of intestinal tissue. The condition is most often diagnosed in babies who are born prematurely.

Signs and symptoms of NEC include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools.

Who is at Risk?
Premature infants currently receiving hospital care and premature infants discharged from the hospital within the past 30 days should not be fed SimplyThick...

What Does the Product Look Like?
SimplyThick is one brand of thickening agent available to medical centers and consumers. 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...

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256253.htm

[Missouriwatcher]

Re: FDA: Do Not Feed SimplyThick to Premature Infants

June 4, 2011 - St. Louis, MO -- Simply Thick, LLC is announcing a voluntary recall of its SimplyThick? thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia since June 1, 2009. This plant is currently owned and operated by Thermo Pac, LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Georgia plant. Simply Thick products manufactured at two additional food processing plants are not subject to this voluntary recall...

WHY THE VOLUNTARY RECALL WAS ANNOUNCED
The SimplyThick? thickening gel products manufactured at the Thermo Pac, LLC Stone Mountain plant are being recalled because the U.S. Food and Drug Administration (FDA) advised the company that Thermo Pac, LLC failed to file with the FDA a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. This failure was discovered during an FDA inspection of the Thermo Pac, LLC Stone Mountain plant conducted from May 23 through June 3, 2011.

HOW TO IDENTIFY THE PRODUCT
Products manufactured at the Stone Mountain, GA plant subject to the voluntary recall were distributed across the United States and Canada through food service distributors, drug distributors, retail outlets (consisting primarily of pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers.

HOW TO DETERMINE IF THE PRODUCT WAS MANUFACTURED AT THE STONE MOUNTAIN GA PLANT
Products affected are 15 g, 30 g, 120 g and 240 g pouches.
All 15 g pouches are affected
All 30 g pouches are affected
Some 120 g pouches ? identified as those with a ?TP? in the lot code stamped into the edge of the packet.
Some 240 g pouches ? identified as those with a ?TP? in the lot code stamped into the edge of the packet.

SimplyThick item numbers affected
ALL 01001, 01005, 01007, 02001, 02005, and 02007
SOME 01004, 02004, 01006 and 02006 ? identified as those with a ?TP? in the lot code stamped into the edge of the packet.
SimplyThick item numbers are included as part of the UPC barcode on our packaging. The item number is the second group of 5 digits in the UPC barcode.

All products have a code embossed or stamped in the foil. The first 6 digits of that code represent a ?best if used by? date in MMDDYY format. ANY date code that falls between 062610 (i.e. June 26, 2010) and 062612 (i.e. June 26, 2012) and contains the letter code ?TP? in the code are affected by the recall.

An example of an affected date code is: 0312125TP1. The code breakdown would be the ?Best If Used By Date?, 03/12/12 ? i.e. March 12, 2012 AND it contains ?TP? in the code . A picture of a packet with this date code can be found on our website.

A complete list of affected date codes will be posted on the SimplyThick website at www.simplythick.com/recalleddatecodes within the next day...

SHOULD THE FDA WARNING CONTINUE TO BE FOLLOWED REGARDING PREMATURE BABIES?
Yes...

http://www.fda.gov/Safety/Recalls/ucm257841.htm?s_cid=w_c_sms_cont_001