Thromboembolic adverse events associated with TPO-RA in ITP treatment: a pharmacovigilance analysis of the FDA Adverse Event Reporting System - PubMed
6 hours ago
- #pharmacovigilance
- #TPO-RA
- #thromboembolic events
- Thrombopoietin receptor agonists (TPO-RA) are used for immune thrombocytopenia (ITP), but their thromboembolic safety profiles need further characterization.
- A pharmacovigilance analysis of FDA Adverse Event Reporting System (FAERS) data from 2009 to 2024 identified 2,092 unique thromboembolic adverse event (AE) cases linked to TPO-RAs.
- Avatrombopag, Eltrombopag, and Romiplostim were associated with different thromboembolic events, with Avatrombopag showing the strongest signal for renal vein thrombosis.
- Median time to thromboembolic event onset was 81 days, with 25% occurring within 25 days of treatment.
- Risk factors for thromboembolic events included age >85 years, body weight >100 kg, and treatment duration >730 days.
- Eltrombopag and Romiplostim were associated with lower reporting odds of thromboembolic AEs compared to Avatrombopag.
- The study highlights the need for proactive risk stratification and sustained thrombosis surveillance in patients receiving TPO-RAs.