1*School of Pharmaceutical and Population Health Informatics, DIT University, Dehradun, Uttarakhand (248009). Email: nitin.rajpoot95@gmail.com
2School of Pharmaceutical and Population Health Informatics, DIT University, Dehradun, Uttarakhand (248009). Email: mmmarora2@gmail.com
3Pharmacovigilance Programme of India (PvPI), National Coordination Centre, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India. Email: vivekarts@gmail.com
4Department of Pharmacy, Metro College of Health Sciences & Research, Noida, Uttar Pradesh, India. Email: rajputshivangi1997@gmail.com
Background: Filgrastim and pegfilgrastim granulocyte colony-stimulating factors (G-CSFs) are widely used in oncology, yet their cardiac safety profiles need a systemic pharmacovigilance evaluation.
Objectives: To detect and compare cardiac adverse-event reporting signals for filgrastim and pegfilgrastim biosimilars using EudraVigilance and FAERS.
Methods: Disproportionality analyses were conducted from market authorization through 30 June 2024 in reports where filgrastim or pegfilgrastim biosimilars were recorded as suspect drugs and at least one Preferred Term (PT) under the System Organ Class (SOC) "Cardiac disorders". The top 30 cardiac PTs (highest reporting frequency within each database) were evaluated. Metrics included ROR with 95% confidence interval, PRR, χ², and IC025.
Results: EudraVigilance included 953 cardiac reports (filgrastim n=583; pegfilgrastim n=370) and identified three strong statistical signals: filgrastim-cardiotoxicity (ROR 28.32; 95% CI 1.710-469.014), filgrastim-pericarditis (ROR 2.49; 95% CI 1.005-6.179), and pegfilgrastim-cardiac disorder (ROR 2.52; 95% CI 1.346-4.705). FAERS included 2,020 drug-associated cardiac reports after exclusions and identified 12 strong signals. Concordant strong statistical signals across both databases were filgrastim-cardiotoxicity, filgrastim-pericarditis, and pegfilgrastim-cardiac disorder.
Conclusions: Dual-database signal detection identified three strong statistical signals within cardiac disorders, supporting prioritization for further validation in longitudinal healthcare datasets.
Keywords: Filgrastim; pegfilgrastim; pharmacovigilance; disproportionality analysis; EudraVigilance; FAERS; cardiac disorders.
How to cite this article: Kumar N, Arora MK, Kalaiselvan V, Rajput S. Disproportionality Signal Analysis of Cardiac Adverse Events Associated with Filgrastim and Pegfilgrastim using EudraVigilance and FAERS. Int J Drug Deliv Technol. 2026;16(13s): 480-492. DOI: 10.25258/ijddt.16.13s.52
Source of support: Nil.
Conflict of interest: None