%0 Journal Article
%A Dubrall, Diana
%A Wicherski, Julia
%A Below, Maike
%A Görtzen-Patin, Jan
%A Schmid, Matthias
%A Zenker, Sven
%A Haenisch, Britta
%A Sachs, Bernhardt
%T Analyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases.
%J Drugs in R & D
%V 25
%N 1
%@ 1174-5886
%C [Erscheinungsort nicht ermittelbar]
%I Springer International
%M DZNE-2025-00553
%P 35 - 55
%D 2025
%X In November 2018, the European Medicines Agency (EMA) restricted the use of fluoroquinolones (used by mouth, injections or inhalation) in the context of a referral due to long-lasting and potentially irreversible adverse drug reactions (ADRs). Fluoroquinolones should no longer be used to treat mild or moderate bacterial infections unless other antibacterials cannot be used.The first aim of our study was to analyze whether in the period before compared with after the referral the characteristics of spontaneous ADR reports related to fluoroquinolones differed and whether specific ADRs were more frequently reported for fluoroquinolones compared with cotrimoxazole. Secondly, we analyzed whether the ADR profile differed between individual fluoroquinolones. Finally, the number of fluoroquinolone reports was considered in relation to the number of outpatient drug prescriptions.All spontaneous ADR reports from Germany received before the referral (01/2014-12/2019) and after the referral (01/2020-12/2022) for adults in which fluoroquinolones (n = 2575; n = 967) or cotrimoxazole (n = 299, n = 275) were reported as suspected/interacting were identified in the European ADR database, EudraVigilance. The ADR reports were descriptively analyzed concerning the reported characteristics. Odds ratios (ORs) and their 95
%K Humans
%K Fluoroquinolones: adverse effects
%K Anti-Bacterial Agents: adverse effects
%K Male
%K Middle Aged
%K Female
%K Adverse Drug Reaction Reporting Systems: statistics & numerical data
%K Adult
%K Referral and Consultation
%K Germany: epidemiology
%K Aged
%K Trimethoprim, Sulfamethoxazole Drug Combination: adverse effects
%K Drug-Related Side Effects and Adverse Reactions: epidemiology
%K Pharmacovigilance
%K Databases, Factual
%K Fluoroquinolones (NLM Chemicals)
%K Anti-Bacterial Agents (NLM Chemicals)
%K Trimethoprim, Sulfamethoxazole Drug Combination (NLM Chemicals)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:39833604
%2 pmc:PMC12011694
%R 10.1007/s40268-024-00499-x
%U https://pub.dzne.de/record/278047