Thromboembolism adverse event profiles of thrombopoietin receptor agonists: a real-world, pharmacovigilance study.

Background: Thrombopoietin receptor agonists (TPO-RAs) are currently approved for the treatment of thrombocytopenia in different conditions. The relationship between TPO-RAs and thromboembolic events (TEEs) remains controversial.

Research design and methods: We extracted TPO-RAs adverse reaction reports after their marketing until now, using the FDA adverse event reporting system (FAERS). Positive signals were detected by reporting odds ratios (RORs). And the Weibull shape parameter test was utilized to analyze the time-to-onset profiles.

Result: Thromboembolic events accounted for 8.97% among TPO-RAs reports. Increased reporting of TEEs was related to TPO-RAs treatment compared with the entire FAERS database [ROR = 2.65 (2.56, 2.73)]. In addition, venous thrombotic events [ROR = 4.13 (3.92, 4.35)] were reported more frequently than arterial events ROR = 1.81 (1.7, 1.93)]. Age over 60 years [odds ratio (OR) = 1.10 (1.01, 1.20), p = 0.029] and weight over 80 kg [OR = 1.36 (1.17, 1.58), p < 0.001] of patients might have higher risk of TEEs during TPO-RAs therapy.

Conclusion: Evidence from the real world suggested that TPO-RAs were associated with higher incidence of TEEs, particularly venous thrombosis. The risk of TPO-RAs-associated TEEs mostly happened in the early stages of treatment and decreased over time.