FDA Says “SimplyThick” Shouldn’t Be Given To Premature Infants

The U.S. Food and Drug Administration (FDA) is warning parents, caretakers, and health care providers not to use <"http://www.yourlawyer.com/practice_areas/product_liability">SimplyThick in feedings to premature infants born before 37 weeks. The thickening product, used in the management of swallowing disorders, may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.

The FDA first learned of adverse events possibly linked to SimplyThick 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 about which the agency is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of infants who later developed NEC and who were given the product to help with swallowing difficulties stemming from complications of premature birth.

NEC most often occurs in babies within the hospital early in their premature course; however, some of the ill babies involved were discharged from the hospital on a feeding regimen that included SimplyThick. The babies fell ill at home.

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

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

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.

The FDA is investigating the link between SimplyThick and these illnesses and deaths and said it will provide updates as information is made available.

Meanwhile, Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by: Completing and submitting the adverse report online: www.fda.gov/MedWatch/report.htm; downloading the pre-addressed, postage-paid FDA Form 3500 (at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or by 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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