Abstract
Background: Eltrombopag and romiplostim are thrombopoietin receptor agonists approved for treating thrombocytopenia in various conditions. Post-marketing surveillance data provide valuable insights into their real-world safety profiles.
Objective: To analyze adverse event reports for eltrombopag and romiplostim from the FDA Adverse Event Reporting System (FAERS) database to characterize their safety profiles and identify potential safety signals.
Methods: We analyzed FAERS reports for eltrombopag and romiplostim from 2015 to 2024. Reports were classified by System Organ Class (SOC), seriousness criteria, patient demographics, time to onset, and clinical outcomes. Descriptive statistics were used to characterize adverse event patterns.
Results: A total of 3500 adverse event reports were identified (eltrombopag: n=2262; romiplostim: n=1238). Mean patient age was 57.5 years for eltrombopag and 58.5 years for romiplostim, with female predominance (57.6% and 56.4%, respectively).
For eltrombopag, the most frequently reported adverse events were hepatic disorders, with 29.8% of reports involving hepatobiliary events. The top adverse events included ALT increased (n=124), bilirubin increased (n=120), jaundice (n=117), AST increased (n=109), and hepatic failure (n=107). Thrombotic events occurred in 20.5% of eltrombopag reports. The serious adverse event rate was 51.3%, with a mortality rate of 3.3%.
For romiplostim, injection site reactions were the most common adverse events, occurring in 18.3% of reports. The most frequently reported events were injection site reaction (n=80), injection site erythema (n=76), and injection site pain (n=71). Thrombotic events occurred in 23.3% of romiplostim reports. The serious adverse event rate was 48.6%, with a mortality rate of 2.7%.
The median time to onset was similar for both drugs (eltrombopag: 74 days; romiplostim: 73 days), with most events occurring within 90 days of treatment initiation. Geographic distribution showed predominant reporting from the United States, followed by Japan and European countries.
Conclusions: This FAERS analysis confirms known safety profiles of both thrombopoietin receptor agonists. Eltrombopag demonstrates a clear hepatic safety signal requiring regular liver function monitoring, while romiplostim shows expected injection site reactions. Both drugs exhibit similar rates of thrombotic complications. These findings support current prescribing guidelines emphasizing the need for appropriate patient monitoring and risk-benefit assessment in clinical practice.
Keywords: eltrombopag, romiplostim, thrombopoietin receptor agonists, FAERS, pharmacovigilance, thrombocytopenia, adverse drug reactions
