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@ARTICLE{Wicherski:276749,
      author       = {Wicherski, Julia and Peltner, Jonas and Becker, Cornelia
                      and Schüssel, Katrin and Brückner, Gabriela and
                      Schlotmann, Andreas and Schröder, Helmut and Kern, Winfried
                      V and Haenisch, Britta},
      title        = {{H}igh risk for life-threatening adverse events of
                      fluoroquinolones in young adults: a large {G}erman
                      population-based cohort study.},
      journal      = {BMC medicine},
      volume       = {23},
      number       = {1},
      issn         = {1741-7015},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DZNE-2025-00307},
      pages        = {76},
      year         = {2025},
      abstract     = {Fluoroquinolone 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.},
      keywords     = {Humans / Germany: epidemiology / Female / Male /
                      Fluoroquinolones: adverse effects / Adult / Middle Aged /
                      Anti-Bacterial Agents: adverse effects / Aged / Cohort
                      Studies / Young Adult / Arrhythmias, Cardiac: chemically
                      induced / Arrhythmias, Cardiac: epidemiology / Aortic
                      Dissection: epidemiology / Aortic Dissection: chemically
                      induced / Chemical and Drug Induced Liver Injury:
                      epidemiology / Chemical and Drug Induced Liver Injury:
                      etiology / Adolescent / Drug-Related Side Effects and
                      Adverse Reactions: epidemiology / Age Factors / Risk Factors
                      / Adverse drug reactions (Other) / Antibiotics (Other) /
                      Cohort study (Other) / Fluoroquinolones (Other) / Real-world
                      evidence (Other) / Fluoroquinolones (NLM Chemicals) /
                      Anti-Bacterial Agents (NLM Chemicals)},
      cin          = {AG Hänisch},
      ddc          = {610},
      cid          = {I:(DE-2719)1013010},
      pnm          = {354 - Disease Prevention and Healthy Aging (POF4-354)},
      pid          = {G:(DE-HGF)POF4-354},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39920723},
      pmc          = {pmc:PMC11806691},
      doi          = {10.1186/s12916-025-03919-0},
      url          = {https://pub.dzne.de/record/276749},
}