Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database

ABSTRACT

Background

The potential risks of denosumab on pediatric patients have raised concerns about its safety. This article aims to analyze the adverse effects of denosumab in minors, with a specific focus on hypercalcemia.

Research design and methods

A case study involving a child was analyzed. The OpenVigil 2.1 was utilized to extract adverse event data from the FAERS database, focusing on denosumab as the primary suspect drug in pediatric patients. The study also reviewed published cases of children developing hypercalcemia after discontinuing denosumab.

Results

The incidence of denosumab induced hypercalcemia in individuals under 18 years old is significantly higher than the overall incidence. The signal value for hypercalcemia was higher in the male group and was highest in the adolescent group. Hypercalcemia usually appeared approximately 4 months after denosumab discontinuation. Males had a higher peak blood calcium level. Patients aged 0–11 years had a higher average peak serum calcium compared to aged 12–17 years.

Conclusions

This study highlights the risk of hypercalcemia after discontinuation of denosumab in minors, with young age and male gender identified as potential high-risk factors. These findings offer valuable safety warnings and preventative measures for the secure administration of this drug in pediatric populations.

KEYWORDS:

• Children
• denosumab
• FAERS
• hypercalcemia
• adverse events

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (Approval Number: 2024-E001-01). Written informed consent was obtained from the patient’s parents.

Acknowledgments

We would like to thank the patient’s parents for their informed consent.

Author contribution statement

ST conceived and designed the study. YC and CF conducted the database search, performed data analysis, created figures, and contributed to writing and reviewing the manuscript. ZY, GQ, and ST participated in data interpretation. All authors contributed to the article and approved the submitted version.

Additional information

Funding

This paper was funded by Guangxi University teachers research basic ability improvement project [2023KY0119] and Medical empowerment project [CRCF-YXFN-202301004].