Risk assessment of colchicine-associated neurological adverse events based on FAERS database

doi:10.19803/j.1672-8629.20230531

Abstract

Abstract: Objective To evaluate the neurological adverse events (nAEs) caused by colchicine and provide evidence for safe use of colchicine in stroke. Methods The nAEs related to colchicine that occurred between 2004 and 2022 were retrieved from the FDA Adverse Event Reporting System (FAERS) database to mine the signals via disproportionality analysis and Bayesian analysis. Results A total of 906 cases of colchicine-associated nAEs were collected, and the top three nAEs were headache (ROR₀₂₅=1.09, IC₀₂₅=0.30), and hypoaesthesia (ROR₀₂₅=1.79, IC₀₂₅=1.09), and loss of consciousness(ROR₀₂₅=1.62, IC₀₂₅=0.99). Overall, no signal was detected in the ischaemic and haemorrhagic disorders of the central nervous system. The median onset-time of colchicine-associated nAEs was 30d while the fatality rate was 7.42%. Conclusion Although no association is found between colchicine and ischaemic and haemorrhagic disorders of the central nervous system, more attention should be paid to some other rare neurological AEs during clinical practice.

Key words: colchicine, central nervous system, neurotoxic, ischemic, hemorrhagic, FDA Adverse Event Reporting System (FAERS), adverse event, data mining

CLC Number:

R994.11

WU Tingxi, ZHAO Zhigang, SHI Yanfeng, ZHANG Yang, ZHANG Yinan, ZHU Bin. Risk assessment of colchicine-associated neurological adverse events based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 341-345.

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https://www.zgywjj.com/EN/Y2024/V21/I3/341

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