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Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children
AUDIENCE: Consumer
ISSUE: The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
BACKGROUND: Homeopathic teething tablets and gels are distributed by CVS, Hyland's, and possibly others, and are sold in retail stores and online.
RECOMMENDATION: The FDA recommends that consumers stop using these products and dispose of any in their possession. Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
Read the MedWatch safety alert, including a link to the FDA News Release, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523435.htm
美國FDA發布藥品安全警訊，市售用於緩解嬰幼兒長牙不適之藥品和凝膠可能引起癲癇等副作用。美國FDA呼籲消費者應立即停止使用此類藥品。
此類藥品未經美國FDA審查其安全性及療效及核准，也未能證實此藥品是否確實能緩解嬰幼兒的長牙不適症狀。
若孩童使用後出現疑似癲癇、呼吸困難、昏睡、異常嗜睡、肌肉無力、皮膚發紅、便秘、排尿困難或躁動等症狀，請立即就醫治療。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523435.htm
[Posted 10/01/2016]
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
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