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000278047 041__ $$aEnglish
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000278047 1001_ $$00000-0002-8763-051X$$aDubrall, Diana$$b0
000278047 245__ $$aAnalyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases.
000278047 260__ $$a[Erscheinungsort nicht ermittelbar]$$bSpringer International$$c2025
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000278047 520__ $$aIn 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.
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000278047 650_7 $$2NLM Chemicals$$aFluoroquinolones
000278047 650_7 $$2NLM Chemicals$$aAnti-Bacterial Agents
000278047 650_7 $$08064-90-2$$2NLM Chemicals$$aTrimethoprim, Sulfamethoxazole Drug Combination
000278047 650_2 $$2MeSH$$aHumans
000278047 650_2 $$2MeSH$$aFluoroquinolones: adverse effects
000278047 650_2 $$2MeSH$$aAnti-Bacterial Agents: adverse effects
000278047 650_2 $$2MeSH$$aMale
000278047 650_2 $$2MeSH$$aMiddle Aged
000278047 650_2 $$2MeSH$$aFemale
000278047 650_2 $$2MeSH$$aAdverse Drug Reaction Reporting Systems: statistics & numerical data
000278047 650_2 $$2MeSH$$aAdult
000278047 650_2 $$2MeSH$$aReferral and Consultation
000278047 650_2 $$2MeSH$$aGermany: epidemiology
000278047 650_2 $$2MeSH$$aAged
000278047 650_2 $$2MeSH$$aTrimethoprim, Sulfamethoxazole Drug Combination: adverse effects
000278047 650_2 $$2MeSH$$aDrug-Related Side Effects and Adverse Reactions: epidemiology
000278047 650_2 $$2MeSH$$aPharmacovigilance
000278047 650_2 $$2MeSH$$aDatabases, Factual
000278047 7001_ $$0P:(DE-2719)9000812$$aWicherski, Julia$$b1
000278047 7001_ $$aBelow, Maike$$b2
000278047 7001_ $$aGörtzen-Patin, Jan$$b3
000278047 7001_ $$0P:(DE-HGF)0$$aSchmid, Matthias$$b4
000278047 7001_ $$00000-0003-0774-0725$$aZenker, Sven$$b5
000278047 7001_ $$0P:(DE-2719)2810511$$aHaenisch, Britta$$b6
000278047 7001_ $$00000-0001-8260-0891$$aSachs, Bernhardt$$b7
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