Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS)...

Area of Science:

• Pharmacovigilance and Drug Safety
• Clinical Pharmacology
• Bone Metabolism and Oncology

Background:

• Denosumab is a critical therapeutic agent for osteoporosis and various cancers.
• Hypocalcemia is a frequently observed adverse event associated with denosumab treatment.
• Real-world data analysis is crucial for understanding drug safety profiles.

Purpose of the Study:

• To investigate the incidence and characteristics of hypocalcemia adverse events linked to denosumab.
• To evaluate the safety signal of denosumab-induced hypocalcemia using real-world data from the FDA Adverse Event Reporting System (FAERS).
• To compare the hypocalcemia risk of denosumab with bisphosphonates.

Main Methods:

• Utilized data from the FAERS database spanning January 1, 2017, to December 31, 2021.
• Included only cases where hypocalcemia was suspected as an adverse event of denosumab.
• Employed pharmacovigilance methods, including reporting odds ratios (ROR), to assess safety signals.

Main Results:

• Identified 1042 cases of denosumab-related hypocalcemia among 102,413 denosumab reports.
• Median patient age was 70 years, with a majority being male; median onset was 23 days.
• Denosumab demonstrated a significant safety signal for hypocalcemia (ROR=14.09), particularly in cancer patients (ROR=21.28) and compared to bisphosphonates (ROR=1.88).

Conclusions:

• Denosumab is associated with a substantial safety signal for hypocalcemia.
• The risk of hypocalcemia is notably higher in cancer patients undergoing denosumab treatment.
• Findings underscore the importance of monitoring calcium levels during denosumab therapy.