TY  - JOUR
AU  - Dubrall, Diana
AU  - Wicherski, Julia
AU  - Below, Maike
AU  - Görtzen-Patin, Jan
AU  - Schmid, Matthias
AU  - Zenker, Sven
AU  - Haenisch, Britta
AU  - Sachs, Bernhardt
TI  - Analyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases.
JO  - Drugs in R & D
VL  - 25
IS  - 1
SN  - 1174-5886
CY  - [Erscheinungsort nicht ermittelbar]
PB  - Springer International
M1  - DZNE-2025-00553
SP  - 35 - 55
PY  - 2025
AB  - 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
KW  - Humans
KW  - Fluoroquinolones: adverse effects
KW  - Anti-Bacterial Agents: adverse effects
KW  - Male
KW  - Middle Aged
KW  - Female
KW  - Adverse Drug Reaction Reporting Systems: statistics & numerical data
KW  - Adult
KW  - Referral and Consultation
KW  - Germany: epidemiology
KW  - Aged
KW  - Trimethoprim, Sulfamethoxazole Drug Combination: adverse effects
KW  - Drug-Related Side Effects and Adverse Reactions: epidemiology
KW  - Pharmacovigilance
KW  - Databases, Factual
KW  - Fluoroquinolones (NLM Chemicals)
KW  - Anti-Bacterial Agents (NLM Chemicals)
KW  - Trimethoprim, Sulfamethoxazole Drug Combination (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:39833604
C2  - pmc:PMC12011694
DO  - DOI:10.1007/s40268-024-00499-x
UR  - https://pub.dzne.de/record/278047
ER  -