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Characterization of Adverse Drug Effects to Three Radiopharmaceuticals: A Descriptive Analysis from WHO-VigiAccess
Yiheng Jin1, Kunlun Gui1,2, Kaixin Chen1
1School of Public Health, Zhejiang Provincial Key Laboratory of Watershed Science and Health, Wenzhou Medical University, Wenzhou, China.
Cancer Biotherapy & Radiopharmaceuticals
|May 8, 2026
Summary
Real-world data show distinct adverse drug reaction profiles for radiopharmaceuticals Lutathera, Pluvicto, and Xofigo. Careful monitoring and risk assessment are crucial for safe patient treatment with these advanced cancer therapies.
Area of Science:
- Nuclear medicine
- Oncology
- Pharmacovigilance
Background:
- Radiopharmaceuticals are increasingly used for neuroendocrine tumors and advanced prostate cancer.
- Clinical use of radiopharmaceuticals is linked to adverse drug reactions (ADRs) impacting patient safety.
- Real-world data from spontaneous reporting systems, like WHO's VigiAccess, can assess post-marketing drug safety.
Purpose of the Study:
- To analyze and compare the safety profiles of three radiopharmaceuticals: lutetium (177Lu) dotatate (Lutathera), lutetium (177Lu) vipivotide tetraxetan (Pluvicto), and radium (223Ra) dichloride (Xofigo).
- To identify distinct patterns of adverse drug reactions (ADRs) associated with each radiopharmaceutical using real-world data.
Main Methods:
- A retrospective descriptive analysis of 17,743 ADR reports from the WHO-VigiAccess database up to November 2024.
- Extraction and analysis of reports for Lutathera, Pluvicto, and Xofigo, focusing on patient demographics, geographic distribution, and ADRs classified by MedDRA System Organ Class and Preferred Terms.
- Descriptive statistics were employed to compare the safety profiles of the three agents.
Main Results:
- Lutathera showed ADRs mainly in gastrointestinal and skin/subcutaneous tissues.
- Pluvicto had more general systemic disorders and a higher rate of fatal outcomes, consistent with its use in advanced prostate cancer.
- Xofigo was primarily associated with hematological and musculoskeletal toxicities. Distinct ADR patterns were observed alongside 169 common ADRs.
Conclusions:
- WHO-VigiAccess data reveal clearly differentiated ADR profiles for Lutathera, Pluvicto, and Xofigo.
- These findings underscore the need for individualized risk assessment and careful patient monitoring.
- Further prospective investigations are recommended to optimize the safe clinical application of these radiopharmaceuticals.
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