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@ARTICLE{Dubrall:278047,
      author       = {Dubrall, Diana and Wicherski, Julia and Below, Maike and
                      Görtzen-Patin, Jan and Schmid, Matthias and Zenker, Sven
                      and Haenisch, Britta and Sachs, Bernhardt},
      title        = {{A}nalyses of {A}dverse {D}rug {R}eactions to
                      {F}luoroquinolones in {S}pontaneous {R}eports {B}efore and
                      {A}fter the {R}eferral and in {C}linical {R}outine {C}ases.},
      journal      = {Drugs in R $\&$ D},
      volume       = {25},
      number       = {1},
      issn         = {1174-5886},
      address      = {[Erscheinungsort nicht ermittelbar]},
      publisher    = {Springer International},
      reportid     = {DZNE-2025-00553},
      pages        = {35 - 55},
      year         = {2025},
      abstract     = {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 $95\%$
                      confidence intervals (CIs) were estimated by logistic
                      regression analyses, which were performed to investigate
                      whether aortic aneurysms, retinal detachments, cardiac
                      arrhythmias, peripheral polyneuropathies, nervous system
                      disorders, toxic liver diseases and non-traumatic injuries
                      of muscles, tendons and synovialis were more frequently
                      reported for fluoroquinolones compared with cotrimoxazole.
                      Stratified analyses between fluoroquinolones were conducted
                      by calculating ORs and their $95\%$ CIs by using two-by-two
                      tables. Reporting rates were calculated by dividing the
                      number of fluoroquinolone reports by the number of
                      fluoroquinolone prescriptions.Reporting rates of
                      fluoroquinolones clearly increased until 2019 and decreased
                      afterward. Only minor differences in the characteristics of
                      fluoroquinolone reports (e.g., regarding the indications)
                      were observed in reports received before and after the
                      referral. In both periods, peripheral neuropathies, nervous
                      system, and muscle and tendon disorders were more often
                      reported for fluoroquinolones than cotrimoxazole. In the
                      pooled fluoroquinolone-stratified analyses, (i) peripheral
                      neuropathies and nervous system disorders were more
                      frequently reported for ciprofloxacin, (ii) non-traumatic
                      injuries of muscle, tendon, and synovialis were more often
                      reported for levofloxacin, and (iii) cardiac arrhythmias and
                      toxic liver diseases were more frequently reported for
                      moxifloxacin compared with the other fluoroquinolones.In
                      accordance with a reminder sent by the EMA referring to
                      prescribing trends for fluoroquinolones, our study showed
                      that the characteristics of spontaneous ADR reports for
                      fluoroquinolones after the referral were similar to those
                      before the referral, underlining the importance of adhering
                      to the recommended restrictions issued by the EMA. In
                      addition, we observed individual differences between
                      ciprofloxacin, levofloxacin, and moxifloxacin with regard to
                      their ADR profile. Further studies are needed to confirm our
                      results.},
      keywords     = {Humans / Fluoroquinolones: adverse effects / Anti-Bacterial
                      Agents: adverse effects / Male / Middle Aged / Female /
                      Adverse Drug Reaction Reporting Systems: statistics $\&$
                      numerical data / Adult / Referral and Consultation /
                      Germany: epidemiology / Aged / Trimethoprim,
                      Sulfamethoxazole Drug Combination: adverse effects /
                      Drug-Related Side Effects and Adverse Reactions:
                      epidemiology / Pharmacovigilance / Databases, Factual /
                      Fluoroquinolones (NLM Chemicals) / Anti-Bacterial Agents
                      (NLM Chemicals) / Trimethoprim, Sulfamethoxazole Drug
                      Combination (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:39833604},
      pmc          = {pmc:PMC12011694},
      doi          = {10.1007/s40268-024-00499-x},
      url          = {https://pub.dzne.de/record/278047},
}