PMID- 38375685
OWN - NLM
STAT- Publisher
LR  - 20240220
IS  - 1552-4604 (Electronic)
IS  - 0091-2700 (Linking)
DP  - 2024 Feb 20
TI  - A Real-World Pharmacovigilance Study of Ceftazidime/Avibactam: Data Mining of the 
      Food and Drug Administration Adverse Event Reporting System Database.
LID - 10.1002/jcph.2420 [doi]
AB  - 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.
CI  - (c) 2024, The American College of Clinical Pharmacology.
FAU - Yao, Haiping
AU  - Yao H
AD  - Department of Pharmacy, The First College of Clinical Medical Science, China 
      Three Gorges University, Hubei, P. R. China.
AD  - College of Pharmacy, Hubei University of Chinese Medicine, Hubei, P. R. China.
FAU - Wang, Yanyan
AU  - Wang Y
AD  - Department of Pharmacy, The First College of Clinical Medical Science, China 
      Three Gorges University, Hubei, P. R. China.
FAU - Peng, Yan
AU  - Peng Y
AD  - Department of Pharmacy, The First College of Clinical Medical Science, China 
      Three Gorges University, Hubei, P. R. China.
FAU - Huang, Zhixiong
AU  - Huang Z
AD  - Department of Pharmacy, The First College of Clinical Medical Science, China 
      Three Gorges University, Hubei, P. R. China.
FAU - Gan, Guoping
AU  - Gan G
AD  - College of Pharmacy, Hubei University of Chinese Medicine, Hubei, P. R. China.
FAU - Wang, Zhu
AU  - Wang Z
AUID- ORCID: 0000-0002-4401-0281
AD  - Department of Pediatrics, The First College of Clinical Medical Science, China 
      Three Gorges University, Hubei, P. R. China.
LA  - eng
PT  - Journal Article
DEP - 20240220
PL  - England
TA  - J Clin Pharmacol
JT  - Journal of clinical pharmacology
JID - 0366372
SB  - IM
OTO - NOTNLM
OT  - FAERS
OT  - MDR-GNB
OT  - ceftazidime/avibactam
OT  - data mining
OT  - pharmacovigilance
EDAT- 2024/02/20 11:51
MHDA- 2024/02/20 11:51
CRDT- 2024/02/20 05:31
PHST- 2023/11/27 00:00 [received]
PHST- 2024/02/01 00:00 [accepted]
PHST- 2024/02/20 11:51 [medline]
PHST- 2024/02/20 11:51 [pubmed]
PHST- 2024/02/20 05:31 [entrez]
AID - 10.1002/jcph.2420 [doi]
PST - aheadofprint
SO  - J Clin Pharmacol. 2024 Feb 20. doi: 10.1002/jcph.2420.