Safety evaluation of ceftazidime/avibactam based on FAERS database: Safety evaluation of ceftazidime/avibactam: Zhang et al.
Objective: To explore adverse event (AE) signals of Ceftazidime/avibactam (CZA) based on the FDA Adverse Event Reporting System (FAERS) database. Methods: AE reports primarily associated with CZA were retrieved from the FAERS database from the second quarter of 2015 to the second quarter of 2023. Si...
| Publicado en: | Infection Vol. 52; no. 6; pp. 2195 - 2206 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Dec2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=181463188&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 181463188 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 03008126 NXO jtl: Infection issn: 03008126 maglogo: N pubinfo: dt: Dec2024 vid: 52 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 181463188 177689843 181463188 181463188 10.1007/s15010-024-02248-3 181463188 ppf: 2195 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Safety evaluation of ceftazidime/avibactam based on FAERS database: Safety evaluation of ceftazidime/avibactam: Zhang et al. aug: au: Zhang, Xiuhong Jiang, Ying Guo, Yating Zhou, Wenbo Qiao, Weizhen Zhu, Haohao Qi, Zhigang affil: Department of Pharmacy, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Medical Center, Nanjing Medical University, Wuxi, Jiangsu, China sug: subj: Patient Safety Evaluation Drug Combinations Therapeutic Use Ceftazidime Therapeutic Use Drug Combinations Adverse Effects Decision Making, Clinical Adverse Drug Event Risk Factors Risk Assessment United States Food and Drug Administration Databases, Health Human Descriptive Statistics Odds Ratio Confidence Intervals Sex Factors Age Factors Incident Reports Funding Source Hepatotoxicity Anemia, Hemolytic Hypernatremia Liver Abnormalities ab: Objective: To explore adverse event (AE) signals of Ceftazidime/avibactam (CZA) based on the FDA Adverse Event Reporting System (FAERS) database. Methods: AE reports primarily associated with CZA were retrieved from the FAERS database from the second quarter of 2015 to the second quarter of 2023. Signal detection was conducted using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods. Results: A total of 750 AEs reports with CZA as the preferred suspected drug were obtained, identifying 66 preferred terms (PTs) involving 24 system organ classes (SOCs). Besides, the AEs already mentioned in the drug label, this study also revealed some new, clinically valuable potential AEsignals, such as Cholestasis (n = 14, ROR 29.39, PRR 29.15, IC 3.34, EBGM 29.11), Drug-induced liver injury (n = 8, ROR 9.05, PRR 9.01, IC 2.25, EBGM 9.01), Hepatocellular injury (n = 7, ROR 13.90, PRR 13.84, IC 2.41, EBGM 13.63), Haemolytic anaemia (n = 5, ROR 24.29, PRR 24.22, IC 2.42, EBGM 40.53), etc. Additionally, AE signals with higher intensity were identified, such as Hypernatraemia (n = 5, ROR 40.73, PRR 40.61, IC 2.31, EBGM 24.19), Toxic epidermal necrolysis (n = 4, ROR 11.58, PRR 11.55, IC 1.89, EBGM 11.54). Therefore, special vigilance for these potential AEs is warranted when using CZA clinically. Conclusion: This study highlights the potential AEs and risks associated with the clinical use of CZA, particularly the risks related to Cholestasis, Drug-induced liver injury, Haemolytic anaemia, Hypernatraemia, and Toxic epidermal necrolysis. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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