Simply Thick Recall Information & FAQs
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 Regarding The Dangers of Simply Thick
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 include:
Important Information for Caregivers Using Simply Thick
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.
Simply Thick Recall FAQs
Q: Why Was Simply Thick Recalled?
A: SimplyThick products manufactured at the Thermo Pac, LLC plant in Stone Mountain, Georgia were voluntarily recalled because the FDA advised the company that Thermo Pac failed to file with the FDA a scheduled process to make sure that harmful bacteria was destroyed during the manufacturing process.
Q: How Can these Harmful Bacteria Affect My Child?
A: Exposure to bacteria is a possible risk factor for necrotizing enterocolitis (NEC), an infection/irritation of the intestinal lining which typically affects premature infants and some newborns.
Q: How Do You Treat Necrotizing Enterocolitis?
A: Immediately contact your doctor. Normally, NEC demands immediate admittance to a hospital for specialized care. Affected children are fed via IV to allow time for the intestines to heal with the use of antibiotics to prevent or treat infection. Sometimes surgery is required to remove infected intestinal tissue.
Q: How Do I know If I Have Contaminated a Simply Thick Product?
A: The contaminated SimplyThick products are as follows:
All 15 g pouches
All 30 g pouches
Some 120 g pouches identified with a “TP” in the lot code stamped on the edge of the packet
Some 240 g pouches identified with a “TP” in the lot code stamped on the edge of the packet
Additional information on specific item numbers can be found on the FDA website.
Q: How Do I Know If My Child Has Been Affected By Contaminated Simply Thick?
A: Children may experience a bloated stomach, lack of bowel movements or increased frequency in bowel movements, green or discolored vomit, chronic abdominal pains, or other intestinal problems. However, a doctor needs to perform medical tests to determine the extent of injuries and determine the link to Simply Thick.
For More Information Contact A Legal Professional
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