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000276749 1001_ $$0P:(DE-2719)9000812$$aWicherski, Julia$$b0$$udzne
000276749 245__ $$aHigh risk for life-threatening adverse events of fluoroquinolones in young adults: a large German population-based cohort study.
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000276749 520__ $$aFluoroquinolone antibiotics have a high potential for serious adverse drug reactions, but real-world evidence in European patient cohorts is lacking. Therefore, we aim to examine the association between fluoroquinolone exposure and potentially life-threatening adverse events stratified by age and gender in Germany.We conducted an administrative cohort study using the active comparator new user design with a risk window up to 365 days between January 2013 and December 2019. Population-based longitudinal data from one of the largest German statutory health insurances were used. Episodes of newly dispensed fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, and enoxacin) were compared to other antibiotics (amoxicillin, amoxicillin clavulanic acid, azithromycin, cefuroxime, cephalexin, clindamycin, sulfamethoxazole-trimethoprim, and doxycycline). Endpoints were defined by incident diagnoses of aortic aneurysm/dissection, cardiac arrhythmia, hepatotoxicity, and all-cause mortality. Adjusted hazard ratios were estimated from piece-wise exponential additive mixed models with smooth non-linear effects for person-time and age and adjusted for comorbidities, year and quarter at index.The cohorts comprised 15,139,840; 11,760,159; 11,027,175; and 15,305,757 antibiotic episodes. Patients during fluoroquinolone episodes were older (59 versus 51 years) and more often female (58% versus 54%). We counted 46,502; 446,727; 19,125; and 474,411 incident endpoints. Relative risk for all-cause mortality and hepatotoxicity was high for < 40-year- and 40-69-year-old females (aHR = 1.77, 95% CI 1.55-2.03 and aHR = 1.42, 95% CI 1.32-1.53), respectively. For aortic aneurysm/dissection a nominally increased relative risk for < 40-year-old females was found (aHR = 1.42, 95% CI 0.96-2.11), although 95% CI indicates that a small relative risk reduction is also supported by the data. Relative risk for cardiac arrhythmia was increased for men aged < 40 years (aHR = 1.14, 95% CI 1.08-1.20). High relative risks for each endpoint were also identified depending on choice of active comparator, and risks increased with higher defined daily doses and shorter follow-up.This study contributes real-world evidence to endpoint-specific differences of risks in patient subgroups which need to be considered to improve fluoroquinolone drug safety.
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000276749 650_7 $$2Other$$aAdverse drug reactions
000276749 650_7 $$2Other$$aAntibiotics
000276749 650_7 $$2Other$$aCohort study
000276749 650_7 $$2Other$$aFluoroquinolones
000276749 650_7 $$2Other$$aReal-world evidence
000276749 650_7 $$2NLM Chemicals$$aFluoroquinolones
000276749 650_7 $$2NLM Chemicals$$aAnti-Bacterial Agents
000276749 650_2 $$2MeSH$$aHumans
000276749 650_2 $$2MeSH$$aGermany: epidemiology
000276749 650_2 $$2MeSH$$aFemale
000276749 650_2 $$2MeSH$$aMale
000276749 650_2 $$2MeSH$$aFluoroquinolones: adverse effects
000276749 650_2 $$2MeSH$$aAdult
000276749 650_2 $$2MeSH$$aMiddle Aged
000276749 650_2 $$2MeSH$$aAnti-Bacterial Agents: adverse effects
000276749 650_2 $$2MeSH$$aAged
000276749 650_2 $$2MeSH$$aCohort Studies
000276749 650_2 $$2MeSH$$aYoung Adult
000276749 650_2 $$2MeSH$$aArrhythmias, Cardiac: chemically induced
000276749 650_2 $$2MeSH$$aArrhythmias, Cardiac: epidemiology
000276749 650_2 $$2MeSH$$aAortic Dissection: epidemiology
000276749 650_2 $$2MeSH$$aAortic Dissection: chemically induced
000276749 650_2 $$2MeSH$$aChemical and Drug Induced Liver Injury: epidemiology
000276749 650_2 $$2MeSH$$aChemical and Drug Induced Liver Injury: etiology
000276749 650_2 $$2MeSH$$aAdolescent
000276749 650_2 $$2MeSH$$aDrug-Related Side Effects and Adverse Reactions: epidemiology
000276749 650_2 $$2MeSH$$aAge Factors
000276749 650_2 $$2MeSH$$aRisk Factors
000276749 7001_ $$0P:(DE-2719)9002192$$aPeltner, Jonas$$b1$$udzne
000276749 7001_ $$0P:(DE-2719)9000482$$aBecker, Cornelia$$b2$$udzne
000276749 7001_ $$aSchüssel, Katrin$$b3
000276749 7001_ $$aBrückner, Gabriela$$b4
000276749 7001_ $$aSchlotmann, Andreas$$b5
000276749 7001_ $$aSchröder, Helmut$$b6
000276749 7001_ $$aKern, Winfried V$$b7
000276749 7001_ $$0P:(DE-2719)2810511$$aHaenisch, Britta$$b8$$eLast author$$udzne
000276749 773__ $$0PERI:(DE-600)2131669-7$$a10.1186/s12916-025-03919-0$$gVol. 23, no. 1, p. 76$$n1$$p76$$tBMC medicine$$v23$$x1741-7015$$y2025
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