{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T11:09:07Z","timestamp":1779361747838,"version":"3.51.4"},"reference-count":45,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2025,11,17]],"date-time":"2025-11-17T00:00:00Z","timestamp":1763337600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Risk &amp; Safety in Medicine"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Due to the rising prevalence of resistant bacteria, there is a growing tendency to prescribe fluoroquinolones (FQs) to pediatric patients. Real world safety parameters of FQs in children may be studied using data of national pharmacovigilance databases.\n                      <jats:italic toggle=\"yes\">The aim<\/jats:italic>\n                      of our study was to estimate the structure of adverse drug reactions (ADR) associated with FQs in pediatric patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>retrospective study of spontaneous reports registered in Russian National Pharmacovigilance database\u2013Automatized Information System \u201cPharmacovigilance\u201d for the period: 1 April 2019\u201331 January 2024.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Total number of pediatric SRs was 280 (19.2%). Mean age was 12.1 \u00b1 5.9\u00a0years (min \u2013 1\u00a0day, max \u2013 18\u00a0years), and adolescents were the most involved age group (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 176, 62.9%). Mean time to ADR onset was 13.9 + 41.0 (min = 0, max = 303) days. Leading FQs were levofloxacin (49.6%,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 139), ciprofloxacin (31.1%,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 87), and moxifloxacin (15%,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 42). Top-5 SOCs included \u201cImmune disorders\u201d (18.9%), \u201cGastrointestinal disorders\u201d (15.0%), \u201cSkin and subcutaneous tissue disorders\u201d (14.7%), \u201cGeneral disorders and administration site conditions\u201d (11.7%), and \u201cInvestigations\u201d (7.6%). Top-5 PTs were urticaria, diarrhea, rash, arthralgia, and pruritus.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Levofloxacin, ciprofloxacin, and moxifloxacin were the primary FQs linked to ADRs in the pediatric population. Most prevalent were allergic reactions. Children receiving FQs should be closely monitored from the start of treatment throughout their entire hospital stay and for an extended period following discharge.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09246479251398995","type":"journal-article","created":{"date-parts":[[2025,11,18]],"date-time":"2025-11-18T04:33:44Z","timestamp":1763440424000},"page":"168-181","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety of fluoroquinolones in pediatric patients: Pharmacovigilance database analysis"],"prefix":"10.1177","volume":"37","author":[{"given":"Olga","family":"Butranova","sequence":"first","affiliation":[{"name":"Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4859-4322","authenticated-orcid":false,"given":"Yury","family":"Kustov","sequence":"additional","affiliation":[{"name":"Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sergey","family":"Zyryanov","sequence":"additional","affiliation":[{"name":"Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN)"},{"name":"State Budgetary Institution of Healthcare of the City of Moscow"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irina","family":"Asetskaya","sequence":"additional","affiliation":[{"name":"Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizaveta","family":"Terehina","sequence":"additional","affiliation":[{"name":"Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN)"},{"name":"Record and Analysis of Circulation of Medical Products Under the Federal Service for Surveillance in Healthcare"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vitaly","family":"Polivanov","sequence":"additional","affiliation":[{"name":"Record and Analysis of Circulation of Medical Products Under the Federal Service for Surveillance in Healthcare"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gleb","family":"Putsman","sequence":"additional","affiliation":[{"name":"Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN)"},{"name":"State Budgetary Institution of Healthcare of the City of Moscow"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,11,17]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.36488\/cmac.2023.4.395-400"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkae440"},{"key":"e_1_3_4_4_2","unstructured":"Highlights of prescribing information for CIPRO (Ciprofloxacin hydrochloride) (2016). 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