Key result
Anticoagulants, particularly warfarin, heparin, and apixaban, are linked to increased calciphylaxis safety signals.
Why the study?
Data regarding the involvement of anticoagulants in calciphylaxis remain limited despite its serious and potentially fatal nature.
Are anticoagulants associated with an increased risk of calciphylaxis?
Observational (n=471)
Are anticoagulants associated with an increased risk of calciphylaxis?
Pharmacovigilance data and literature review suggest a safety signal for calciphylaxis associated with anticoagulants, particularly warfarin, warranting caution in high-risk populations.
Signals warrant vigilance for calciphylaxis with warfarin or heparin; hypothesis-generating and leaves causality open for prospective study.
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.
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Sridharan et al. (2024) conducted an observational in Calciphylaxis (n=471). Anticoagulants (warfarin, heparin, apixaban) was evaluated on Disproportionality signals for calciphylaxis. Anticoagulants, particularly warfarin, heparin, and apixaban, were associated with disproportionality signals for calciphylaxis based on 471 unique adverse event reports.
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