Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System
This study indicates that eltrombopag manifests significant safety signals within the hepatic system. This implies that monitoring liver function during treatment is advisable. Avatrombopag shows relatively lower hepatotoxicity signals; however, further large-scale studies are needed to validate these observations. Moreover, both romiplostim and eltrombopag therapies may be linked to a risk of sudden hearing loss or deafness, which merits clinical attention. These findings offer crucial safety references for clinical drug use. Nevertheless, the causal relationship between the drugs and AEs necessitates further in-depth investigation.
Authors
- Wei Zhuang (ORCID: https://orcid.org/0000-0002-1720-8882)
- Yunsong Li (ORCID: https://orcid.org/0000-0002-0640-4060)
- Xiaoling Wang (ORCID: https://orcid.org/0009-0006-0474-6071)
Institutions
- Xiamen University (CN)
Publication Details
- Journal
- BMC Pharmacology and Toxicology
- Published
- 2025-02-27
- DOI
- https://doi.org/10.1186/s40360-025-00873-8
- Citations
- 4
- Primary Topic
- Platelet Disorders and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 7.08
Funders
- Natural Science Foundation of Xiamen City
- Natural Science Foundation of Fujian Province