澳大利亚警示含穿心莲产品的严重过敏反应风险
澳大利亚医疗产品局(TGA)于2015年10月8日发布信息,称经对穿心莲的安全性评价后发现其存在潜在的过敏反应风险,包括严重的过敏反应,警示消费者和医护人员使用含中药成分穿心莲相关产品的过敏反应。
2002年12月至2014年4月期间,TGA共收到与含穿心莲产品相关的43例过敏反应报告和78例其它过敏样反应报告。TGA经过安全性评估认为,穿心莲可能导致这些不良反应或在这些不良反应中起促进作用,包括用于多成分制剂时。
穿心莲在一些营养补充剂中作为一种草药成分使用,属于爵床科,穿心莲传统上用于缓解发热、缓解感冒症状、缓解咽喉痛、缓解胃肠道紊乱和急性腹泻、辅助轻度呼吸道感染的恢复。
含穿心莲的产品列于澳大利亚治疗用品登记册(Australian Register of Therapeutic Goods,ARTG),适应症比较宽泛。目前在澳大利亚,将穿心莲用于药物尚无限制或在标签上进行警示。TGA目前正考虑是否需要进一步采取措施,与此同时将继续监测含有穿心莲的产品。
相关链接:http://www.sda.gov.cn/WS01/CL0389/146020.html
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