Adverse events in patients with castration-resistant prostate cancer treated with ra-223: a retrospective pharmacovigilance study.

Background: Radium-223 (Ra-223) received U.S. Food and Drug Administration (FDA) approval for treating castration-resistant prostate cancer with symptomatic bone metastases, excluding visceral metastases. Despite this, the safety profile of Ra-223 in large-scale, population-based use still needs to be explored.

Research design and methods: This research assesses the side effects of Ra-223 by analyzing reports of adverse events (AEs) from the FDA's Adverse Event Reporting System (FAERS) database. Four sequential analysis strategies were employed to assess the significance of these AEs.

Results: In total, 4,228 Ra-223-related AE reports were identified in the FAERS database. These Ra-223-induced AEs were observed in 26 target system organ classes (SOCs). 124 Ra-223-induced AEs were detected in 26 SOCs, predominantly affecting the blood and lymphatic systems. Other notable AEs included diarrhea, nausea, asthenia, fatigue, malaise, and decreased appetite, some of which were not previously documented in product specifications. The median time to onset of AEs was 56 days (Interquartile Range 26-103 days), with the majority of AEs occurring within the first three months after Ra-223 administration.

Conclusions: Our findings align with clinical observations and suggest potential new and unexpected AEs related to Ra-223, underscoring the need for prospective clinical studies to confirm these results and clarify their relationships. These insights provide valuable evidence for further safety studies and the rational use of Ra-223.