FDA警告：增稠剂SimplyThick用于任何年龄婴儿均可致坏死性小肠结肠炎

圣路易斯(MD Consult)——2012年9月18日，美国食品药品管理局(FDA)发布了一则关于使用SimplyThick的最新安全性通告，这是一种帮助解决吞咽困难的增稠剂产品。2011年5月，FDA曾发布安全警告，建议公众不要用该产品喂养早产儿，因其可能引发坏死性小肠结肠炎(NEC)，部分婴儿因此需要接受住院治疗，有的甚至不幸死亡。现FDA警告称，对任何年龄的婴儿使用SimplyThick都可能带来NEC风险。

在2011年公布了这条警示信息后，FDA对可能与SimplyThick相关的健康问题报告进行了广泛的评估，评估结果近期已发表在《儿科学杂志》(Journal of Pediatrics)上。结果显示，在摄入SimplyThick后最终被诊断为NEC的20多名婴儿中，有1名是足月产婴儿。

未来还需开展进一步的研究以明确摄入SimplyThick与NEC发病之间是否确实存在相关性。与此同时，FDA也希望参与婴儿照护的每个人在决定是否将该产品用于任何年龄的婴儿时都能意识到这一潜在风险。

SimplyThick既有小袋包装也有64盎司瓶装，在经销商和全美各地的药房都能买到。可添加到母乳和婴儿配方奶中，起到辅助吞咽的作用，同时也可以防止婴儿吐奶。该产品也可用于因咽喉损伤而出现吞咽问题的大龄儿童和成年人。

与使用SimplyThick相关的不良反应可直接上报至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On September 18, 2012, the US Food and Drug Administration (FDA) issued a safety update concerning the use of SimplyThick, a brand of thickening agent used to help manage swallowing difficulties. In May 2011, the FDA issued a safety alert, advising the public not to use the product when feeding premature infants because of the risk of necrotizing enterocolitis (NEC). Some of the affected infants required hospitalization and some died. The FDA is now warns that infants of any age may be at risk for NEC if they are given SimplyThick.

After issuing the warning in 2011, the FDA conducted an extensive review of reports of health problems potentially tied to SimplyThick. The findings, published recently in the Journal of Pediatrics, included the discovery that 1 infant born at full term was among the almost two dozen ultimately found to experience NEC after ingesting SimplyThick.

Further study is needed to determine whether an actual link exists between consumption of SimplyThick and the development of NEC. In the meantime, the FDA wants everyone involved in infant care to be aware of this potential risk when making the decision to use the product in infants of any age.

SimplyThick is sold in individual serving packets as well as in 64-ounce dispenser bottles and can be purchased from distributors and local pharmacies throughout the United States. It has been used as an additive is to breast milk and infant formula to aid infants in swallowing their food, and to help them keep it down without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat.

Adverse effects related to the use of SimplyThick may be reported to the FDA's MedWatch Adverse Event Reporting Program.