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- Title
A Real‐World Pharmacovigilance Study of Ceftazidime/Avibactam: Data Mining of the Food and Drug Administration Adverse Event Reporting System Database.
- Authors
Yao, Haiping; Wang, Yanyan; Peng, Yan; Huang, Zhixiong; Gan, Guoping; Wang, Zhu
- Abstract
Ceftazidime/avibactam (CAZ/AVI) is a combination of a well‐known third‐generation, broad‐spectrum cephalosporin with a new beta‐lactamase inhibitor that has been approved for the treatment of various infectious diseases (especially multidrug‐resistant Gram‐negative bacterial infections) by the Food and Drug Administration (FDA). The current study extensively assessed CAZ/AVI‐related adverse events (AEs) in the real world through data mining of the FDA Adverse Event Reporting System (FAERS) database to better understand toxicities. The signals of CAZ/AVI‐related AEs were quantified using disproportionality analyses, including the reporting odds ratio, the proportional reporting ratio, the Bayesian confidence propagation neural network, and the multi‐item gamma Poisson shrinker algorithms. Out of 10,114,815 records retrieved from the FAERS database, 628 cases were identified, where CAZ/AVI was implicated as the primary suspect drug. A total of 61 preferred terms with significant disproportionality that simultaneously met the criteria of all four algorithms were retained. Several unexpected safety signals may also occur, including melena, hypernatremia, depressed level of consciousness, brain edema, petechiae, delirium, and shock hemorrhagic. The median onset time for AEs associated with CAZ/AVI was 4 days, with most cases occurring within 3 days after CAZ/AVI initiation.
- Subjects
COMMUNICABLE diseases; COMBINATION drug therapy; PHARMACOLOGY; DRUG toxicity; RISK assessment; DATABASES; POISSON distribution; DRUG side effects; DATA mining; GASTROINTESTINAL hemorrhage; PURPURA (Pathology); UNITED States. Food &; Drug Administration; RETROSPECTIVE studies; ODDS ratio; ARTIFICIAL neural networks; DELIRIUM; CEFTAZIDIME; BETA lactamases; HEMORRHAGIC shock; ALGORITHMS; TIME; RECTUM; HYPERNATREMIA; CONSCIOUSNESS disorders; CEREBRAL edema; CHEMICAL inhibitors
- Publication
Journal of Clinical Pharmacology, 2024, Vol 64, Issue 7, p820
- ISSN
0091-2700
- Publication type
Article
- DOI
10.1002/jcph.2420