FDA Warns Not to Feed Simply Thick to Premature Infants
SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It 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.
FDA continues to work with the Centers for Disease Control and Prevention (CDC) investigating a possible link between SimplyThick and necrotizing enterocolitis (NEC) in premature infants as early indications have suggested. Necrotizing enterocolitis (NEC) is a disease where the tissue in the intestines becomes inflamed and dies.
FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists. At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.
This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.
Symptoms to Watch for:
- bloated stomach
- greenish-tinged vomiting
- bloody stools
Advice for Parents and Caregivers:
- Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
- 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.
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