PMID- 36986665 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230331 IS - 1999-4923 (Print) IS - 1999-4923 (Electronic) IS - 1999-4923 (Linking) VI - 15 IP - 3 DP - 2023 Mar 1 TI - Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile? LID - 10.3390/pharmaceutics15030804 [doi] LID - 804 AB - Antibacterial fluoroquinolones (FQs) are frequently used in treating infections. However, the value of FQs is debatable due to their association with severe adverse effects (AEs). The Food and Drug Administration (FDA) issued safety warnings concerning their side-effects in 2008, followed by the European Medicine Agency (EMA) and regulatory authorities from other countries. Severe AEs associated with some FQs have been reported, leading to their withdrawal from the market. New systemic FQs have been recently approved. The FDA and EMA approved delafloxacin. Additionally, lascufloxacin, levonadifloxacin, nemonoxacin, sitafloxacin, and zabofloxacin were approved in their origin countries. The relevant AEs of FQs and their mechanisms of occurrence have been approached. New systemic FQs present potent antibacterial activity against many resistant bacteria (including resistance to FQs). Generally, in clinical studies, the new FQs were well-tolerated with mild or moderate AEs. All the new FQs approved in the origin countries require more clinical studies to meet FDA or EMA requirements. Post-marketing surveillance will confirm or infirm the known safety profile of these new antibacterial drugs. The main AEs of the FQs class were addressed, highlighting the existing data for the recently approved ones. In addition, the general management of AEs when they occur and the rational use and caution of modern FQs were outlined. FAU - Rusu, Aura AU - Rusu A AUID- ORCID: 0000-0003-4979-6903 AD - Pharmaceutical and Therapeutical Chemistry Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142 Targu Mures, Romania. FAU - Munteanu, Alexandra-Cristina AU - Munteanu AC AUID- ORCID: 0000-0003-1281-3749 AD - Department of General and Inorganic Chemistry, Faculty of Pharmacy, Carol Davila University of Medicine and Pharmacy, 6 Traian Vuia Str., 020956 Bucharest, Romania. FAU - Arbanasi, Eliza-Mihaela AU - Arbanasi EM AD - Pharmaceutical and Therapeutical Chemistry Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142 Targu Mures, Romania. FAU - Uivarosi, Valentina AU - Uivarosi V AUID- ORCID: 0000-0002-7165-5069 AD - Department of General and Inorganic Chemistry, Faculty of Pharmacy, Carol Davila University of Medicine and Pharmacy, 6 Traian Vuia Str., 020956 Bucharest, Romania. LA - eng PT - Journal Article PT - Review DEP - 20230301 PL - Switzerland TA - Pharmaceutics JT - Pharmaceutics JID - 101534003 PMC - PMC10056716 OTO - NOTNLM OT - adverse effects OT - antibacterial quinolones OT - delafloxacin OT - fluoroquinolones OT - lascufloxacin OT - levonadifloxacin OT - nemonoxacin OT - side-effects OT - sitafloxacin OT - zabofloxacin COIS- The authors declare no conflict of interest. EDAT- 2023/03/30 06:00 MHDA- 2023/03/30 06:01 PMCR- 2023/03/01 CRDT- 2023/03/29 02:02 PHST- 2022/11/27 00:00 [received] PHST- 2023/02/07 00:00 [revised] PHST- 2023/02/17 00:00 [accepted] PHST- 2023/03/30 06:01 [medline] PHST- 2023/03/29 02:02 [entrez] PHST- 2023/03/30 06:00 [pubmed] PHST- 2023/03/01 00:00 [pmc-release] AID - pharmaceutics15030804 [pii] AID - pharmaceutics-15-00804 [pii] AID - 10.3390/pharmaceutics15030804 [doi] PST - epublish SO - Pharmaceutics. 2023 Mar 1;15(3):804. doi: 10.3390/pharmaceutics15030804.