Related Experiment Video
Updated: Jul 16, 2025
A Method for Screening and Validation of Resistant Mutations Against Kinase Inhibitors
Published on: December 7, 2014
Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System
Dehua Zhao1, Xiaoqing Long2, Jiping Zhou2
1Department of Clinical Pharmacy, The Third Hospital of Mianyang (Sichuan Mental Health Center), Mianyang, 621000, Sichuan, People's Republic of China. zhaoyaoshi0566@163.com.
Background:
Infigratinib is a fibroblast growth factor receptor (FGFR)-specifc tyrosine kinase inhibitor indicated for the treatment of patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma. However, few studies have been conducted to evaluated the safety of infigratinib in the real world. In this study, we conducted a pharmacovigilance study to evaluate the adverse events (AEs) of infigratinib by using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
OpenVigil 2.1 was employed to extract the FAERS database. Descriptive analysis was used to describe the characteristics of infigratinib-associated AE reports. Disproportionality analysis was performed by calculating the proportional reporting ratio (PRR), reporting odds ratios (ROR), and Bayesian analysis confidence propagation neural network (BCPNN) to detect positive signals.
Results:
Our findings revealed 149 AE reports, among which 36 significant signals were identified. These significant AE signals were mainly observed in gastrointestinal disorders (N = 26, ROR = 26.03, PRR = 8.44, information component [IC] = 3.08) and skin and subcutaneous tissue disorders (N = 21, ROR = 92.13, PRR = 40.41, IC = 5.34). Notably, dehydration and skin exfoliation were unexpected AEs, but had relatively high signal intensities (ROR = 29.75, PRR = 26.64, IC = 4.74; ROR = 50.61, PRR = 45.24, IC = 5.50, respectively) despite not being listed on the drug label. Furthermore, our analysis showed that infigratinib dose differed statistically between severe and non-severe reports (113.82 ± 16.13 mg vs 125 ± 0.00 mg, t = - 4.28; p < 0.001). However, there were no significant differences in sex, age, and types of AEs between the two groups (p = 0.06, p = 0.86, and p = 0.93, respectively).
Conclusions:
These findings suggest that gastrointestinal and skin toxicities are the most common adverse reactions for infigratinib. It is important to recognize skin exfoliation and dehydration in clinical practice, as they are unexpected AEs. Additionally, our study indicates that infigratinib dose may correlate with an increased risk of AE severity, highlighting the need for dose adjustment of infigratinib when exposure to the drug is increased due to internal or external factors.
Insights
This study analyzed real-world adverse events (AEs) for infigratinib, a cancer drug. Gastrointestinal and skin toxicities were most common, with dehydration and skin exfoliation being unexpected AEs requiring clinical attention.
Area of Science:
- Pharmacovigilance
- Oncology
- Drug Safety
Background:
- Infigratinib is an FGFR-specific tyrosine kinase inhibitor for cholangiocarcinoma.
- Real-world safety data for infigratinib remains limited.
- This study utilized the FAERS database to assess infigratinib's adverse events.
Purpose of the Study:
- To evaluate the safety profile of infigratinib in a real-world setting.
- To identify and characterize adverse events associated with infigratinib treatment.
- To detect potential safety signals using pharmacovigilance methods.
Main Methods:
- A pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database.
- Descriptive analysis of infigratinib-associated adverse event reports.
- Disproportionality analysis (PRR, ROR, BCPNN) to detect safety signals.
Main Results:
- 149 adverse event reports were analyzed, identifying 36 significant safety signals.
- Gastrointestinal disorders (26 reports) and skin/subcutaneous tissue disorders (21 reports) were the most frequent.
- Unexpected adverse events with high signal intensities included dehydration and skin exfoliation; lower infigratinib doses correlated with non-severe events.
Conclusions:
- Gastrointestinal and skin toxicities are primary adverse reactions to infigratinib.
- Clinicians should be aware of unexpected adverse events like skin exfoliation and dehydration.
- Infigratinib dosage may influence the severity of adverse events, suggesting a need for dose adjustment.
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:11Clinical Trials: Overview
01:25Drug Regulation
01:23Dipeptidyl Peptidase 4 Inhibitors
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...