Safety of romiplostim and eltrombopag for children with immune thrombocytopenia : a pharmacovigilance study of the FDA adverse event reporting system database
BACKGROUND: Romiplostim and eltrombopag are thrombopoietin receptor agonists (TPORAs) that have been approved by the FDA on 22 August 2008 and 20 November 2008 for pediatric immune thrombocytopenia (ITP). However, postmarketing pharmacovigilance of TPORAs in children still attracts much attention. We aimed to evaluate the safety of the TPORAs romiplostim and eltrombopag using data from the Adverse Event Reporting System database of FDA (FAERS).
RESEARCH DESIGN AND METHODS: We conducted a disproportionality analysis and analyzed data from the FAERS database to characterize the key features of adverse events (AEs) associated with TPO-RAs approved for children under 18 years of age.
RESULTS: Since their approval in the market in 2008, 250 and 298 reports of romiplostim and eltrombopag use in children have been published in the FAERS database, respectively. The most frequent AE associated with romiplostim and eltrombopag was epistaxis. Neutralizing antibodies and vitreous opacities showed the strongest signals for romiplostim and eltrombopag, respectively.
CONCLUSIONS: The labeled AEs for romiplostim and eltrombopag in children were analyzed. Unlabeled AEs may reflect the potential of new clinical individuals. Early recognition and management of AEs that appear in children treated with romiplostim and eltrombopag are of key importance in clinical practice.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
|---|---|
| Enthalten in: |
Expert opinion on drug safety - 22(2023), 8 vom: 20. Juli, Seite 707-714 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fang, Qiongtong [VerfasserIn] |
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| Links: |
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| Themen: |
Adverse events |
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| Anmerkungen: |
Date Completed 02.11.2023 Date Revised 02.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/14740338.2023.2182288 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM353097624 |
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| 100 | 1 | |a Fang, Qiongtong |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety of romiplostim and eltrombopag for children with immune thrombocytopenia |b a pharmacovigilance study of the FDA adverse event reporting system database |
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| 500 | |a Date Revised 02.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Romiplostim and eltrombopag are thrombopoietin receptor agonists (TPORAs) that have been approved by the FDA on 22 August 2008 and 20 November 2008 for pediatric immune thrombocytopenia (ITP). However, postmarketing pharmacovigilance of TPORAs in children still attracts much attention. We aimed to evaluate the safety of the TPORAs romiplostim and eltrombopag using data from the Adverse Event Reporting System database of FDA (FAERS) | ||
| 520 | |a RESEARCH DESIGN AND METHODS: We conducted a disproportionality analysis and analyzed data from the FAERS database to characterize the key features of adverse events (AEs) associated with TPO-RAs approved for children under 18 years of age | ||
| 520 | |a RESULTS: Since their approval in the market in 2008, 250 and 298 reports of romiplostim and eltrombopag use in children have been published in the FAERS database, respectively. The most frequent AE associated with romiplostim and eltrombopag was epistaxis. Neutralizing antibodies and vitreous opacities showed the strongest signals for romiplostim and eltrombopag, respectively | ||
| 520 | |a CONCLUSIONS: The labeled AEs for romiplostim and eltrombopag in children were analyzed. Unlabeled AEs may reflect the potential of new clinical individuals. Early recognition and management of AEs that appear in children treated with romiplostim and eltrombopag are of key importance in clinical practice | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Adverse events | |
| 650 | 4 | |a FAERS | |
| 650 | 4 | |a children | |
| 650 | 4 | |a eltrombopag | |
| 650 | 4 | |a immune thrombocytopenia | |
| 650 | 4 | |a romiplostim | |
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| 650 | 7 | |a Benzoates |2 NLM | |
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| 700 | 1 | |a Huang, Fuqiang |e verfasserin |4 aut | |
| 700 | 1 | |a Liang, Jiabi |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yishen |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Cheng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Meirong |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Xinrong |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Wenji |e verfasserin |4 aut | |
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