摘要:2018年1月,FDA宣布要求修改含可待因或氢可酮的阿片类感冒咳嗽处方药说明书的安全性信息,以限制这些产品只能在18岁及以上成人中使用。FDA同时要求将关于这类药品误用、滥用、成瘾、过量、死亡及呼吸迟缓或困难的安全性信息以最醒目的方式加入到说明书的黑框警告中。
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