Anticoagulant-associated calciphylaxis: analysis of USFDA adverse event report system and clinical feature analysis of reported cases.

BACKGROUND

Calciphylaxis is a serious, potentially fatal condition resulting in pathological calcification of soft tissues. While associated with chronic kidney disease, data regarding anticoagulant involvement remain limited.

RESEARCH DESIGN AND

METHODS

The United States Food and Drug Administration Adverse Event Reporting System (USFDA AERS) database was searched to identify calciphylaxis reports linked to anticoagulants from 2004 to 2024. Disproportionality analyses compared reporting rates versus usage. Literature was reviewed to extract calciphylaxis case details with specific anticoagulants.

RESULTS

Disproportionality signals were observed between calciphylaxis and warfarin, heparin, and apixaban from 471 unique reports. Literature review confirmed an association between warfarin and calciphylaxis based on 54 cases from 48 reports. Risk factors for warfarin-associated calciphylaxis included older age, female sex, and longer duration. Approximately two-thirds responded to sodium thiosulfate, bisphosphonates, or hyperbaric oxygen therapy.

CONCLUSION

This evaluation characterized calciphylaxis safety signals from pharmacovigilance data and literature review. Warfarin emerged as the most strongly associat.ed based on both sources. While limitations preclude causality determination, findings warrant attention regarding warfarin's calciphylaxis risk profile, especially in higher-risk populations. Additional research is needed, including controlled trials, to validate this relationship and optimize management.