Guidance on drug safety from regulatory agencies must be sensibly communicated and based on strong, clear evidence Doctors learn early in their careers about the central importance of communication in medicine. Discussion of the relative risks and benefits of various treatment options, while considering the wider evidence and an individual patient’s circumstances and views, is challenging. The same challenge applies to guidance delivered from central bodies: it must be sensibly communicated, clear, based on published evidence, and applicable to a wide range of individual situations. However, when the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) posted a drug safety update on fluoroquinolones in January 2024, stating that with immediate effect systemic fluoroquinolones “must only be administered when no other antibiotics are appropriate for use,”1 many clinicians were blindsided. Some heard it on the national news before the official email notification arrived. There was no opportunity to prepare alternative prescribing guidelines or to offer any reassurance to patients, as the MHRA hadn’t shared the new evidence on fluoroquinolones that had motivated this drastic and sudden restriction. Fluoroquinolones are known …

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氟喹诺酮类药物：需要更明确的安全性证据和指导

监管机构关于药物安全的指导必须以强有力、明确的证据为基础进行明智的沟通。医生在其职业生涯的早期就了解到沟通在医学中的核心重要性。在考虑更广泛的证据和个体患者的情况和观点的同时，讨论各种治疗方案的相对风险和益处是具有挑战性的。同样的挑战也适用于中央机构提供的指导：它必须明智地传达、清晰、基于已发表的证据，并适用于广泛的个人情况。然而，当英国药品和保健品监管局 (MHRA) 于 2024 年 1 月发布氟喹诺酮类药物安全更新时，指出立即生效的全身性氟喹诺酮类药物“只能在没有其他抗生素适合使用的情况下使用”1，许多临床医生措手不及。在官方电子邮件通知到达之前，一些人在国家新闻中听到了这一消息。没有机会准备替代处方指南或向患者提供任何保证，因为 MHRA 没有分享有关氟喹诺酮类药物的新证据，而正是这些证据促使了这种突然的剧烈限制。氟喹诺酮类药物已知...