Wednesday, May 25, 2011
I received this information in an email from my local office. This information concerns parents and caregivers of premature infants.
KDHE has been notified by the FDA to advise parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants.
This product may be associated with necrotizing enterocolitis (NEC), a life-threatening condition.
Since May 13, 2011 FDA has been notified of 15 cases of NEC, including two deaths, involving premature infants who were given SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products. In Kansas, two cases of NEC have been reported in premature infants that were given this product.
NEC most often occurs in premature infants while still hospitalized. The current situation is unusual because some of the infants had been discharged from the hospital on a feeding regimen that included SimplyThick and then developed symptoms of NEC while at home.
NEC is a life-threatening condition characterized by inflammation and death of intestinal tiss ue. Signs and symptoms of NEC include appearance of a bloated abdominal area, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools.
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. Images of the SimplyThick label and packaging can be viewed at: www.flickr.com/photos/fdaphotos/sets/72157626641899297/.
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 35003 at: www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms /default.htm (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.
For additional information on this investigation please call the FDA at 888-INFO-FDA or the KDHE Epidemiology Hotline at 877-427-7317.