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Central nervous system adverse events of ceftazidime/avibactam: A retrospective study using Food and Drug
Xiaolong Guo1,2,3,4, Mingxing Guo1, Jiyang Li4
1Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
What Is Known And Objective:
Many antibiotics are well known for being associated with adverse events (AEs) of central nervous system, ceftazidime/avibactam (CAZ/AVI) is a novel β-lactam/β-lactamase inhibitor combinations. In this commentary, we analyzed reports of nervous system disorders associated with CAZ/AVI, meropenem, imipenem, ceftazidime, ceftriaxone, and cefepime in the Food and Drug Administration (FDA) Adverse Event Reporting System database from January 2015 to March 2022.
Comment:
The reporting odds ratios (RORs) method was used to detect the safety signals. Up to 15.62% of CAZ/AVI AEs exhibit nervous system disorders associated with CAZ/AVI. A nervous system disorder signal was detected for CAZ/AVI compared with meropenem, ceftazidime, and ceftriaxone. Compared with meropenem, imipenem, ceftazidime, and ceftriaxone, encephalopathy, myoclonus, reported with CAZ/AVI exhibited significant RORs.
What Is New And Conclusion:
This study found that CAZ/AVI showed a relatively stronger sign nervous system disorder than meropenem, ceftazidime, and ceftriaxone in the real world. The poor clinical outcome of these events should attract clinical attention, especially for patients with older than 65 years old and long treatment courses.
Insights
Ceftazidime/avibactam (CAZ/AVI) antibiotics show increased nervous system adverse events compared to other drugs. Clinicians should monitor older patients and those on long treatments for potential neurological side effects.
Area of Science:
- Pharmacovigilance
- Infectious Diseases
- Neurology
Background:
- Antibiotics are frequently linked to central nervous system adverse events.
- Ceftazidime/avibactam (CAZ/AVI) is a newer combination antibiotic.
- Understanding the neurological safety profile of CAZ/AVI is crucial.
Purpose of the Study:
- To analyze and compare nervous system adverse events associated with CAZ/AVI versus other antibiotics.
- To identify specific neurological adverse events linked to CAZ/AVI.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database.
- Analyzed reports from January 2015 to March 2022.
- Employed the reporting odds ratios (RORs) method to detect safety signals.
Main Results:
- Nervous system disorders accounted for up to 15.62% of CAZ/AVI adverse events.
- A significant nervous system disorder signal was detected for CAZ/AVI compared to meropenem, ceftazidime, and ceftriaxone.
- Encephalopathy and myoclonus showed significant RORs with CAZ/AVI.
Conclusions:
- CAZ/AVI demonstrates a stronger signal for nervous system disorders in real-world data compared to meropenem, ceftazidime, and ceftriaxone.
- These neurological events warrant clinical attention, particularly in elderly patients and those undergoing extended treatment courses.
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