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.

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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

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article

Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System

Wei Zhuang, Yunsong Li, Xiaoling Wang
4 citations
BMC Pharmacology and Toxicology
Platelet Disorders and Treatments
7.08
article

Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System

Wei Zhuang, Yunsong Li, Xiaoling Wang
article en
4 citations

Abstract

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.

BMC Pharmacology and ToxicologyVol. 26(1)
Xiamen University (CN)
Natural Science Foundation of Xiamen City, Natural Science Foundation of Fujian Province
Openalex Percentile: Top 4%
Platelet Disorders and Treatments
7.08
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