Neratinib safety evaluation: real-world adverse event analysis from the FAERS database

Area of Science:

• Pharmacovigilance
• Oncology
• Drug Safety

Background:

• Neratinib is a key treatment for breast cancer.
• Numerous adverse drug events (ADEs) associated with neratinib remain unreported.
• Real-world data analysis is crucial for identifying potential safety concerns.

Purpose of the Study:

• To mine and analyze neratinib-related ADE signals from the US FDA Adverse Event Reporting System (FAERS) database.
• To identify previously unrecognized ADEs associated with neratinib.
• To provide insights for the safe and rational clinical use of neratinib.

Main Methods:

• Collected neratinib-related ADE data from the FAERS database (Q3 2017 - Q4 2023).
• Standardized data and applied four disproportionality methods to assess neratinib-ADE correlations.
• Analyzed 1,544 ADEs where neratinib was the primary suspected drug.

Main Results:

• Identified 48 preferred terms (PTs) and 10 system organ classes (SOCs) with significant disproportionality across all four algorithms.
• Key SOCs included gastrointestinal disorders, general disorders, and injury, poisoning, and procedural complications.
• Discovered 34 ADEs at the PT level not documented in the existing neratinib manual.

Conclusions:

• The study provides new real-world evidence on neratinib's drug safety profile.
• While findings largely align with the drug manual, additional undocumented ADEs were identified.
• Further research is necessary to validate these unreported ADEs and ensure neratinib's safety and efficacy.