智通财经APP获悉,美国食品和药物管理局(FDA)周四表示,该局已提议将广泛用于感冒和咳嗽糖浆的口服苯肾上腺素从治疗鼻塞的非处方药的有效成分中移除并称其无效。苯肾上腺素广泛用于各种非处方流感和感冒药中,包括苯海拉明、阿德维尔和泰诺等流行产品。它也是治疗鼻塞的鼻喷雾剂中的一种成分。然而,FDA的行动只涉及口服给药的苯肾上腺素,不涉及鼻腔喷雾剂。
去年,一个外部专家小组一致投票反对口服苯肾上腺素作为减充血剂的有效性,并补充说不需要更多的试验以证明有效性。
宝洁(PG.US)和葛兰素史克(GSK.US)等公司被指控在含有该成分的感冒药上欺骗消费者。
FDA目前正在征求公众对这一拟议命令的意见。
目前,制药公司可能会继续销售含有口服苯肾上腺素作为减充血剂的药品。然而,FDA表示,将为制造商提供适当时间,要么重新配制含有口服苯肾上腺素的药物,要么将此类药物从市场上撤下。
消费者保健产品协会在一份声明中表示,“对FDA提议扭转其长期以来对口服苯肾上腺素的看法感到失望”。该协会补充说,将审查拟议的命令,并提出相应意见。
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