Published: 14 March 2025
Author(s): Charles L Bennett, Linda Martin, Gretchen LeFever Watson, Steven T Rosen, David Aboulafia, SONAR Pharmacovigilance Group
Issue: May 2025
Section: Letter to the Editor

Since fluoroquinolones (FQs) were introduced in 1986, 1 billion courses have been administered [1]. Safety announcements have been disseminated since 2016 in the United States (US), European Union (EU), the United Kingdom (UK), Canada, Australia, and New Zealand describing long-term disabling side effects [2–10]. (see Supplementary materials)) In 2016 and 2018, the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) first disseminated Safety Communications describing a novel FQ-associated long-term toxicity including tendon damage, respiratory insufficiency, peripheral nerve neurotoxicity, and neuropsychiatric effects [1,2,6].

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