Safety evaluation of ceftazidime/avibactam based on FAERS database

Area of Science:

• Pharmacovigilance
• Drug Safety
• Clinical Pharmacology

Background:

• Ceftazidime/avibactam (CZA) is an important antibiotic for treating resistant bacterial infections.
• Understanding its adverse event (AE) profile is crucial for safe clinical use.

Purpose of the Study:

• To identify potential new adverse event (AE) signals associated with Ceftazidime/avibactam (CZA).
• To analyze AE data from the FDA Adverse Event Reporting System (FAERS) database.

Main Methods:

• Retrieved AE reports for CZA from FAERS (Q2 2015–Q2 2023).
• Employed multiple signal detection methods: ROR, PRR, BCPNN, and MGPS.
• Analyzed 750 AE reports, identifying 66 preferred terms across 24 system organ classes.

Main Results:

• Identified known AEs and new potential signals, including Cholestasis, Drug-induced liver injury, Hepatocellular injury, and Haemolytic anaemia.
• Detected high-intensity AE signals such as Hypernatraemia and Toxic epidermal necrolysis.
• Several new AE signals showed significant statistical association (e.g., Cholestasis ROR 29.39, Hypernatraemia ROR 40.73).

Conclusions:

• Ceftazidime/avibactam (CZA) use is associated with potential risks beyond those listed in its label.
• Clinical vigilance is warranted for specific AEs like Cholestasis, Drug-induced liver injury, Haemolytic anaemia, Hypernatraemia, and Toxic epidermal necrolysis.