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A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for denosumab
Yue He1,2, Rong Zhang3, Huarui Shen4
1Sichuan Provincial Ba-Yi Rehablitation Center (Sichuan Provincial Rehablitation Hospital), Chengdu, Sichuan, China.
Background:
Denosumab is authorized to treat several diseases, including cancer and bone disorders. Nevertheless, its use in clinical practice has been affected by safety concerns. The work retrospectively investigated adverse events (AEs) of denosumab to better understand toxicities.
Methods:
The FAERS data base data from Q1 of 2010 to Q3 of 2023 was chosen. The definition of Medical Dictionary for Regulatory Activities (MedDRA) was dependent on preferred terms (PTs) and system organ class (SOCs). Following the removal of duplicate reports, a disproportionality analysis was conducted to identify safety signals through the calculation of reporting odds ratios (ROR).
Results:
During the reporting period, 130611 denosumab-related cases were identified; 670 pTs with a substantial disproportionality were retained. The connective and musculoskeletal tissue disorders, poisoning, injury, and procedural complications, as well as medical and surgical procedures, were among the important SOCs that satisfied the criteria. Reports at PT levels including off-label use, death, osteonecrosis of the jaw, arthralgia, and pain in extremities were determined. Severe consequences in terms of life-threatening injuries and death accounted for 841 and 19704 cases, respectively of the reported cases.
Conclusion:
These findings underscore the critical importance of pharmacovigilance and are consistent with established clinical observations. Notably, osteonecrosis of the jaw, arthralgia, pain in extremities, back pain, myalgia, and bone pain were identified as the most prevalent risk signals associated with denosumab.
Insights
This study analyzed denosumab adverse events (AEs) using FAERS data. Key safety signals included osteonecrosis of the jaw, arthralgia, and pain, highlighting the need for ongoing pharmacovigilance.
Area of Science:
- Pharmacovigilance and drug safety research.
- Clinical toxicology and adverse event analysis.
Background:
- Denosumab is used for cancer and bone disorders but faces safety concerns.
- Understanding denosumab's adverse event profile is crucial for safe clinical use.
Purpose of the Study:
- To retrospectively investigate adverse events (AEs) associated with denosumab.
- To identify safety signals and understand toxicities of denosumab.
Main Methods:
- Utilized the FAERS database from Q1 2010 to Q3 2023.
- Employed disproportionality analysis with reporting odds ratios (ROR) based on MedDRA terms.
- Filtered for preferred terms (PTs) and system organ classes (SOCs) to identify safety signals.
Main Results:
- Identified 130,611 denosumab-related cases, retaining 670 PTs with significant disproportionality.
- Key SOCs included connective/musculoskeletal disorders and procedural complications.
- Prevalent PTs identified were osteonecrosis of the jaw, arthralgia, and pain in extremities; 19,704 cases involved death.
Conclusions:
- Pharmacovigilance is critical for denosumab safety monitoring.
- Osteonecrosis of the jaw, arthralgia, and extremity pain are significant risk signals.
- Findings align with existing clinical observations on denosumab toxicities.
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