Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database

Area of Science:

• Pharmacovigilance
• Drug Safety Analysis
• Clinical Pharmacology

Background:

• Invasive fungal infections (IFIs) pose a significant public health challenge.
• Amphotericin B (AmB) is a critical antifungal agent for IFIs.
• Clinical use of AmB is constrained by its adverse reactions.

Purpose of the Study:

• To mine adverse drug event (ADE) signals for Amphotericin B (AmB) using the FAERS database.
• To identify potential safety concerns and provide a reference for safe clinical application.
• To support clinical monitoring and risk identification of AmB.

Main Methods:

• Analysis of Amphotericin B (AmB) adverse event reports from the FDA Adverse Event Reporting System (FAERS).
• Utilized statistical methods including Reported Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson Shrinker.
• Data mining covered Q1 2004 to Q3 2023.

Main Results:

• 3597 adverse event (AE) reports for AmB were identified, spanning 22 system organ classes (SOCs) and 1355 unique AEs.
• Patients aged 18-60 (47.93%) and female patients (53.82%) showed higher risk for AmB-related AEs.
• High-risk signals included hypokalemia, pyrexia, chills, renal failure, respiratory failure, tachycardia, and deafness.

Conclusions:

• FAERS data analysis reveals critical adverse reaction signals for Amphotericin B (AmB).
• Identified high-risk signals, including those not previously listed in drug instructions, enhance clinical monitoring.
• This study supports improved risk identification and safer clinical management of AmB therapy.