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Global disproportionality analysis of anxiolytic medication-associated cardiovascular and motor impairment disorders, 1967-2024: An international pharmacovigilance database.

Jaehyeong Cho,Kyeongmin Lee,Selin Woo,Jaeyu Park,Hyesu Jo,Jiyeon Oh,Tae Hyeon Kim,Xuerong Wen,G. Fond,Laurent Boyer,Sheng-Min Wang,Suein Choi,D. Yon

Published 2025 in Journal of Affective Disorders

ABSTRACT

BACKGROUND Anxiolytics, commonly prescribed for anxiety disorders, have been reported with various adverse events, but comprehensive research on their cardiovascular and motor side effects is limited. METHODS This study utilized a global pharmacovigilance database, covering 1967 to 2024. We analyzed the incidence of cardiovascular and motor impairment disorders (bradyarrhythmia, coordination abnormality, dysarthria, dyskinesia, and hypotension) reported with anxiolytic use, stratified by sex and age. The information component (IC) with IC025 and reporting odds ratio (ROR) with 95 % CI were calculated using a Bayesian report-non-report analysis. RESULTS Among 887,564 reports of all-cause adverse events in database, 42,301 cases (male, n = 3486 [31.73 %]) were identified as anxiolytic-related. All cardiovascular and motor impairment disorders analyzed showed significant signal detection with anxiolytics, with coordination abnormalities showing the highest ROR (4.69 [95 % CI, 4.50-4.85]; IC, 2.13 [IC025, 2.06]). Benzodiazepines were significantly reported with all five events, as dysarthria showing the highest ROR (8.40 [8.09-8.72]; 3.01 [2.95]). Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) were also detected with anxiolytic-related dysfunctions, except for hypotension. The highest ROR for SNRIs was found in coordination abnormalities (3.58 [3.30-3.88]; 1.81 [1.68]) and for SSRIs in bradyarrhythmia (4.41 [4.29-4.54]; 2.10 [2.06]). CONCLUSION Although our findings did not allow for causal inference, anxiolytics are effective in managing anxiety disorder symptoms, but safety concerns persist, especially related to cardiovascular and motor dysfunctions.

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