Real-world safety profile of fluoroquinolones: a retrospective analysis of the Russian database of spontaneous reports

   Background. Fluoroquinolones continue to be widely used in the treatment of a wide range of infectious diseases, though new risks, including serious, have been identified in the process of their use. In order to maintain a favorable benefit-risk ratio, it is necessary to continue careful monitoring of the real-world safety profile of fluoroquinolones, which may allow, among other things, to develop new approaches to their rational use.

   Objective. To study the structure of adverse reactions (ARs) associated with the use of fluoroquinolones based on a retrospective analysis of the national database of spontaneous reports.

   Materials and methods. A retrospective analysis of spontaneous reports (SRs) received in the Russian database of ARs was carried out from 01.04.2019 to 28.02.2023. Inclusion criteria: SRs with ARs occurred on the territory of the Russian Federation, fluoroquinolone group drug indicated as a suspected drug (SD), identification of a high causal relationship "AR-SD". The Russian
version of MedDRA was used to code and systematize ARs.

   Results. The study included 1890 SRs, out of them 950 were for levofloxacin, 633 for ciprofloxacin, 205 for moxifloxacin, and 102 for other fluoroquinolones. 75.5 % of the received SRs contained information about serious ARs, more than 80 % of ARs developed at the inpatient stage of medical care, self-medication was detected in 2.9 % of cases. 40.8 % of SRs included data on young people; patient age ≥ 75 years was indicated in 7.7 % of SRs; in 75 cases (4.0 %) fluoroquinolones were used in children under 18 years of age. The analysis showed that the most frequently reported ARs were from next 7 system-organ classes (SOC): skin and subcutaneous tissue disorders; gastrointestinal disorders; general disorders and administration site conditions; investigations; respiratory, thoracic and mediastinal disorders, nervous system disorders and immune system disorders. In general, the proportion of these ADRs was 84.1 % with a variation in values in subgroups from 78.2 % for moxifloxacin to 91.9 % for ciprofloxacin.

   Conclusion. The development of a set of measures to improve the general level of knowledge of physicians about the entire spectrum of ARs associated with fluoroquinolones is essential for the rational use of this group. It is necessary to identify not only common, but also clinically significant rare ARs of fluoroquinolones at early stages, and promptly send the information to Roszdravnadzor. Solving these problems will generally improve the safety of antibacterial therapy.

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