Simply Thick Recall Information

'Simply Thick Recall Information'

The Food and Drug Administration (FDA) is advising parents and caregivers of premature infants born before 37 weeks gestation to discontinue usage of Simply Thick thickening products. Simply Thick is a brand of thickening agent used to help manage swallowing difficulties that can be purchased from distributors and pharmacies throughout the United States. The warning stems from recent developments, including a Simply Thick recall, that suggest the products may cause a potentially fatal illness known as necrotizing enterocolitis (NEC) in these infants. NEC is a disease in which intestinal tissue becomes inflamed and can die if not treated quickly.

Background Information
This past May the FDA first received information regarding the possibility that Simply Thick was the cause of several potentially adverse side effects in premature infants. Benson M. Silverman, M.D., director of FDA's Infant Formula and Medical Foods Staff and a neonatologist, said he was first made aware of the situation by two reports in the FDA's MedWatch Adverse Event Reporting system. To date, the FDA has been notified of no less than 15 cases of NEC, including at least two deaths, in premature babies who ingested Simply Thick. The cases feature infants who had been given the thickening agent, in either their mother's breast milk or in baby formula products, for varying amounts of time.

At least four medical centers across the United States have reported these illnesses in premature infants. In all of the cases of which the FDA is currently aware, the child became ill over the past six months. The current situation involving Simply Thick is exceptional because NEC generally is found in hospitalized babies towards the beginning of their premature course. Some of the sick babies of whom FDA is aware, however, had already been discharged from the hospital to their homes, where they were on a diet that included Simply Thick. Only after returning home did these infants begin showing the signs of NEC.

Simply Thick Symptoms to Watch For
•    A slower heart rate
•    Bloated stomach
•    Body temperature issues
•    Breathing problems
•    Diarrhea or bloody stools
•    Discoloration of the belly
•    Distended abdomen
•    Green vomiting
•    Lethargy

Information for Caregivers
Parents, caregivers, and health care providers who are administering Simply Thick to a premature child should stop usage of the product immediately. There is a significant risk that the product may cause necrotizing enterocolitis in these infants. Parents who have questions or concerns about the use of Simply Thick for infants should check with their child's health care provider immediately.

Parents and health care practitioners are also strongly advised to report any symptoms or adverse side effects related to the use of Simply Thick by contacting the FDA's MedWatch and Safety Information and Adverse Event Reporting Program. To contact the program, parents and doctors can do either of the following:

Complete and submit a report online

Download the postage-paid FDA Form 3500 or call 1-800-332-1088 to request the form. After completing the form it should be faxed to 1-800-FDA-0178 or mailed to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

Further Information
If there is a possibility that your child developed NEC due to the use of Simply Thick, it is important for you to contact a Simply Thick recall attorney to know what help you are legally entitled to. The FDA is continuing its investigation into the link between Simply Thick and the illnesses and deaths of premature infants. More information about this topic from WebMD