Expert opinion on drug safety · 2024
A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System.
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Xu Ye, Dai Zhilie, Tian Guowei, He Liqun
Аннотация
BACKGROUND: Colchicine is widely used for gout and familial Mediterranean fever (FMF) and has cardiovascular benefits. However, it is linked to various adverse drug reactions (ADRs). This study aimed to analyze colchicine-related ADRs using FAERS data for safer clinical use.
RESEARCH DESIGN AND METHODS: FAERS data from April 2005 to March 2024 were analyzed using ROR, PRR, BCPNN, and EBGM algorithms. ADRs were categorized by System Organ Classes (SOCs) and Preferred Terms (PTs).
RESULTS: A total of 2,435 colchicine-related ADRs were identified. The most significant SOCs were Injury, poisoning, and procedural complications (n = 1,197, EBGM05 = 6.59) and Gastrointestinal disorders (n = 817, EBGM05 = 7.34). At the PT level, notable ADRs included Neuromyopathy (n = 27, EBGM05 = 153.12), Toxic cardiomyopathy (n = 8, EBGM05 = 138.58), and Spur cell anemia (n = 3, EBGM05 = 88.06). New signals at the PT level, including Necrotizing myositis (n = 6, EBGM05 = 31.22) and Septic arthritis staphylococcal (n = 3, EBGM05 = 28.94), were detected.
CONCLUSIONS: Continuous monitoring is essential to detect established and emerging ADRs. These findings enhance understanding of colchicine's safety profile, with further research needed to validate these signals.
RESEARCH DESIGN AND METHODS: FAERS data from April 2005 to March 2024 were analyzed using ROR, PRR, BCPNN, and EBGM algorithms. ADRs were categorized by System Organ Classes (SOCs) and Preferred Terms (PTs).
RESULTS: A total of 2,435 colchicine-related ADRs were identified. The most significant SOCs were Injury, poisoning, and procedural complications (n = 1,197, EBGM05 = 6.59) and Gastrointestinal disorders (n = 817, EBGM05 = 7.34). At the PT level, notable ADRs included Neuromyopathy (n = 27, EBGM05 = 153.12), Toxic cardiomyopathy (n = 8, EBGM05 = 138.58), and Spur cell anemia (n = 3, EBGM05 = 88.06). New signals at the PT level, including Necrotizing myositis (n = 6, EBGM05 = 31.22) and Septic arthritis staphylococcal (n = 3, EBGM05 = 28.94), were detected.
CONCLUSIONS: Continuous monitoring is essential to detect established and emerging ADRs. These findings enhance understanding of colchicine's safety profile, with further research needed to validate these signals.