Long-term safety of lanthanum carbonate in the real word: a 19-year disproportionality analysis from the FDA Adverse Event Reporting System

ABSTRACT

Background

Lanthanum carbonate is widely used to manage serum phosphate and calcium levels in end-stage kidney disease (ESKD) patients, yet comprehensive long-term safety data are lacking. This study leverages the FDA Adverse Event Reporting System (FAERS) to assess the extended safety profile of lanthanum carbonate.

Research design and methods

We analyzed FAERS data (2004–2022) to study the association between lanthanum carbonate and adverse events (AEs). Using MedDRA v25.0, we identified risk signals through System Organ Classes (SOCs) and Preferred Terms (PTs). Disproportionality analyzes quantified lanthanum carbonate-associated AE signals.

Results

Among 3,284 reports, 2,466 were primary suspected AEs linked to lanthanum carbonate. Males reported AEs more frequently than females. Patients aged over 64 represented the majority. Median onset time for lanthanum carbonate-related AEs was 146 days. Gastrointestinal disorders were prevalent. We identified 16 new signals, including stress, abnormal hepatic function, cholelithiasis, bile duct stone, gastric cancer, and adenocarcinoma gastric. Stress was notable, particularly in male patients over 65 and those with lower weight.

Conclusions

This study affirms lanthanum carbonate’s long-term safety for reducing elevated blood phosphorus levels. While gastrointestinal disorders were common, attention must focus on emerging AEs, particularly stress, especially in elderly patients.

KEYWORDS:

• FAERS
• pharmacovigilance study
• lanthanum carbonate
• adverse event
• stress

Declaration of interest

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.

Author contributions

M. Ying made substantial contributions to study conception and design, acquisition and analysis of data, and was involved in drafting the manuscript. J. Shi and Y. Ling made substantial contributions to the acquisition and analysis of data. L. Liao and T. Shi made substantial contributions to study design, interpretation of data, and supervision or mentorship. L. Cao made substantial contributions to study design and acquisition and interpretation of data. Each author contributed significantly to drafting or revising the manuscript, takes personal responsibility for their own contributions, and agrees to ensure that questions concerning the accuracy or integrity of any part of the work are investigated and resolved as appropriate.

Ethics approval

This study used anonymized information from the database, which is open to the public; therefore, in accordance with the 1964 Helsinki Declaration (and its amendments), institutional ethics approval was not required.

Data availability statement

The data is openly available in the FDA Adverse Event Reporting System Public Dashboard at: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Additional information

Funding

This study was funded by Hospital Pharmacy Research Foundation of Guangdong Province [2023A32] and the Scientific Research Projects of Medical and Health Institutions of Longhua District, Shenzhen [2022106]; Guangdong Provincial Bureau of Traditional Chinese Medicine research project [20231071].