This has been in the news the last couple of days so just wanted to highlight the issue for parents of premature infants and all infants!
What is SimplyThick??
SimplyThick is a brand of thickening agent—available to consumers and medical centers—used to help manage swallowing difficulties. It is sold in individual serving packets as well as in 64-ounce dispenser bottles, which can be purchased from distributors and local pharmacies throughout the United States.
The Food and Drug Administration (FDA) wants parents, caregivers and health care professionals to be aware that infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.
Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died.
Further study is needed to determine if there is an actual link between consumption of SimplyThick and the development of NEC. But, FDA wants everyone involved in the care of a baby to be aware of the potential risk before deciding whether to feed SimplyThick to infants of any age.
Symptoms to watch out for…
- bloated stomach
- greenish-tinged vomiting
- bloody stools
Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
You or your health care professional may report side effects related to using SimplyThick to FDA’s MedWatch by:
- Completing and submitting the report online: www.fda.gov/MedWatch/report.htm;
- Downloading the pre-addressed, postage-paid FDA Form 35006 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or
- Mailing the completed form to MedWatch, 5600 Fishers Lane, Rockville, MD 20857.
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