Nephrotoxicity of New Antibiotics: A Systematic Review
Drug-induced nephrotoxicity is a common and serious problem in clinical practice. We conducted a systematic review of studies reporting nephrotoxicity events associated with antibiotics approved since 2018. The agents assessed included aztreonam/avibactam, cefepime/enmetazobactam, cefiderocol, cefto...
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MDPI AG
2025-07-01
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| author | Panagiotis Stathopoulos Laura T. Romanos Charalampos Loutradis Matthew E. Falagas |
| author_facet | Panagiotis Stathopoulos Laura T. Romanos Charalampos Loutradis Matthew E. Falagas |
| author_sort | Panagiotis Stathopoulos |
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| description | Drug-induced nephrotoxicity is a common and serious problem in clinical practice. We conducted a systematic review of studies reporting nephrotoxicity events associated with antibiotics approved since 2018. The agents assessed included aztreonam/avibactam, cefepime/enmetazobactam, cefiderocol, ceftobiprole, contezolid, gepotidacin, imipenem/cilastatin/relebactam, lascufloxacin, lefamulin, levonadifloxacin, plazomicin, and sulbactam/durlobactam. Literature searches were conducted in PubMed, Scopus, Web of Science, and major pharmacovigilance databases (Vigibase, FAERS, EudraVigilance, EMA, FDA, NMPA, PMDA, and CDSCO) in May 2025, along with reference citation tracking. Studies were included if they reported safety or adverse event data. The risk of bias was assessed using validated tools in accordance with the study design. Out of 2105 potentially relevant records, 74 studies met inclusion criteria, comprising 52 clinical trials, 17 observational studies, 1 registry-based study, 3 case series, and 1 case report. Nephrotoxicity was rarely reported for any of the newly approved antibiotics. No renal adverse events were found in the available studies for aztreonam/avibactam, levonadifloxacin, and contezolid. Most studies were of moderate to high quality; two were classified as low quality. However, nephrotoxicity was inconsistently assessed, with variable definitions and methodologies used. Although current data suggest a low frequency of nephrotoxicity, limitations in study design and reporting preclude firm conclusions. There is a need for post-marketing studies to better characterize renal safety. Clinicians should remain vigilant and continue to monitor for and report renal-related adverse events. |
| format | Article |
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| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
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| series | Toxics |
| spelling | doaj-art-73be1ac7c20a449a8cd27a0fd2e39a5b2025-07-25T13:37:41ZengMDPI AGToxics2305-63042025-07-0113760610.3390/toxics13070606Nephrotoxicity of New Antibiotics: A Systematic ReviewPanagiotis Stathopoulos0Laura T. Romanos1Charalampos Loutradis2Matthew E. Falagas3Alfa Institute of Biomedical Sciences, 9 Neapoleos Street, Marousi, 151 23 Athens, GreeceAlfa Institute of Biomedical Sciences, 9 Neapoleos Street, Marousi, 151 23 Athens, GreeceSchool of Medicine, European University Cyprus, 6 Diogenous Str., Egkomi, Nicosia 2404, CyprusAlfa Institute of Biomedical Sciences, 9 Neapoleos Street, Marousi, 151 23 Athens, GreeceDrug-induced nephrotoxicity is a common and serious problem in clinical practice. We conducted a systematic review of studies reporting nephrotoxicity events associated with antibiotics approved since 2018. The agents assessed included aztreonam/avibactam, cefepime/enmetazobactam, cefiderocol, ceftobiprole, contezolid, gepotidacin, imipenem/cilastatin/relebactam, lascufloxacin, lefamulin, levonadifloxacin, plazomicin, and sulbactam/durlobactam. Literature searches were conducted in PubMed, Scopus, Web of Science, and major pharmacovigilance databases (Vigibase, FAERS, EudraVigilance, EMA, FDA, NMPA, PMDA, and CDSCO) in May 2025, along with reference citation tracking. Studies were included if they reported safety or adverse event data. The risk of bias was assessed using validated tools in accordance with the study design. Out of 2105 potentially relevant records, 74 studies met inclusion criteria, comprising 52 clinical trials, 17 observational studies, 1 registry-based study, 3 case series, and 1 case report. Nephrotoxicity was rarely reported for any of the newly approved antibiotics. No renal adverse events were found in the available studies for aztreonam/avibactam, levonadifloxacin, and contezolid. Most studies were of moderate to high quality; two were classified as low quality. However, nephrotoxicity was inconsistently assessed, with variable definitions and methodologies used. Although current data suggest a low frequency of nephrotoxicity, limitations in study design and reporting preclude firm conclusions. There is a need for post-marketing studies to better characterize renal safety. Clinicians should remain vigilant and continue to monitor for and report renal-related adverse events.https://www.mdpi.com/2305-6304/13/7/606aztreonam/avibactamcefepime/enmetazobactamcefiderocolceftobiprolecontezolidgepotidacin |
| spellingShingle | Panagiotis Stathopoulos Laura T. Romanos Charalampos Loutradis Matthew E. Falagas Nephrotoxicity of New Antibiotics: A Systematic Review Toxics aztreonam/avibactam cefepime/enmetazobactam cefiderocol ceftobiprole contezolid gepotidacin |
| title | Nephrotoxicity of New Antibiotics: A Systematic Review |
| title_full | Nephrotoxicity of New Antibiotics: A Systematic Review |
| title_fullStr | Nephrotoxicity of New Antibiotics: A Systematic Review |
| title_full_unstemmed | Nephrotoxicity of New Antibiotics: A Systematic Review |
| title_short | Nephrotoxicity of New Antibiotics: A Systematic Review |
| title_sort | nephrotoxicity of new antibiotics a systematic review |
| topic | aztreonam/avibactam cefepime/enmetazobactam cefiderocol ceftobiprole contezolid gepotidacin |
| url | https://www.mdpi.com/2305-6304/13/7/606 |
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