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近期,美国FDA宣称,已强化并更新了抗疟药盐酸甲氟喹产品标签上的警告语,即加黑框警告,提醒用药者,本品可能诱发严重的精神类和神经类不良反应。其中,精神类不良反应包括头晕、失衡和耳鸣,神经类不良反应包括焦虑、多疑、抑郁和幻觉。这些神经类不良反应可出现在服药期间,也可持续至服药后数月到数年,甚至是永久性的。此黑框警告内容也已被加入到该药的用药指南和宣传卡片中。
Recently, the U.S. Food and Drug Administration announced that it has strengthened and updated the warning label on the anti-malarial mefloquine hydrochloride product label, warning of adding black boxes to warn users that it may cause serious psychiatric and neurological adverse reactions. Among them, mental adverse reactions include dizziness, imbalance and tinnitus, and neurological adverse reactions include anxiety, suspiciousness, depression and hallucinations. These neurological adverse reactions can occur during the medication, but also continued to months after taking medication to several years, or even permanent. This black box warning has also been added to the drug’s medication guide and promotional card.