| implyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition
AUDIENCE: Consumers, Pediatrics, Emergency medicine
FDA notified parents, caregivers and health care providers not to feed Simply Thick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
BACKGROUND：FDA first learned of adverse events possibly linked to the product 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. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth.
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.
RECOMMENDATION: Health care providers should stop administering the product to premature infants. 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. See the photographs at the link below for images of the product.
Read the MedWatch safety alert, including links to the Press Release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒病人、照護者及醫療人員，不要為早產兒餵食名為Simply Thick的添加劑。Simply Thick是一種可加入液體中的增稠劑，使嬰兒更容易吞咽，但卻可能引起致死性的壞死性小腸結腸炎（necrotizing enterocolitis; NEC）。
FDA第一次收到可能的案例回報是在2011/5/13，至5/20（本文發布日期）止已有15名NEC案例，分別來自於美國至少四家醫學中心，其中包含2例死亡。這項產品是被加在母乳或其他嬰兒食品配方裡，來幫助有吞嚥困難的早產兒，但隨後卻被發現可能引起壞死性小腸結腸炎。此產品透過不同的包裝在美國各地經銷商及藥局販賣。
建議照護者停止餵食此產品給早產兒，且對於使用此產品有疑慮的家長及照護者，應聯繫醫療人員。請上FDA網站連結產品之外觀圖片。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm
[Posted 05/20/2011]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部 |
資料來源：藥師週刊（第1737期）