International journal of clinical pharmacology and therapeutics · 2025
Cardiovascular toxicity associated with sedative drug use: Post-market pharmacovigilance study with disproportionality analysis.
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Ye Pei, Zhang Hewei, Lyu Qiang, Zhang Wangzheqi, Xu Yidi, Ye Xiaofei, Guo Xiaojing
Аннотация
OBJECTIVE: To compare the toxicity of sedatives in critically ill intensive care unit patients and investigate safety concerns using the United States Food and Drug Administration Adverse Event Reporting System and VigiBase databases.
MATERIALS AND METHODS: Disproportionality analysis was used to assess the relationships among midazolam, propofol, and dexmedetomidine and suspected adverse drug reactions. Adverse drug reactions related to sedation in the intensive care unit were identified through systematic organ classification and assessed using Standardized Regulatory Activities Medical Dictionary Analysis Queries.
RESULTS: A total of 12,102 adverse drug reactions were identified with midazolam, propofol, or dexmedetomidine as the primary suspected drug. The cardiovascular system accounted for a significant proportion of the drug reaction systems with strong signals. The strongest preferred term was neonatal hypertension (N = 9; information component = 7.11 (95% confidence interval: 5.97 - 7.87)), propofol infusion syndrome (N = 482; information component = 10.88 (95% confidence interval: 10.73 - 10.99)), and the trigemino-cardiac reflex (N = 7; information component = 10.36 (95% confidence interval: 9.06 - 11.21)) for midazolam, propofol, and dexmedetomidine, respectively. The Standardized Regulatory Activities Medical Dictionary Analysis Queries with the strongest signal across all sedatives were torsade de pointes and shock-associated conditions (N = 679; information component = 4.24 (95% confidence interval: 4.12 - 4.34)).
CONCLUSION: These findings highlight the need for clinicians to consider cardiovascular toxicity when administering sedatives in the intensive care unit, as different sedatives exhibit different adverse reaction profiles.
MATERIALS AND METHODS: Disproportionality analysis was used to assess the relationships among midazolam, propofol, and dexmedetomidine and suspected adverse drug reactions. Adverse drug reactions related to sedation in the intensive care unit were identified through systematic organ classification and assessed using Standardized Regulatory Activities Medical Dictionary Analysis Queries.
RESULTS: A total of 12,102 adverse drug reactions were identified with midazolam, propofol, or dexmedetomidine as the primary suspected drug. The cardiovascular system accounted for a significant proportion of the drug reaction systems with strong signals. The strongest preferred term was neonatal hypertension (N = 9; information component = 7.11 (95% confidence interval: 5.97 - 7.87)), propofol infusion syndrome (N = 482; information component = 10.88 (95% confidence interval: 10.73 - 10.99)), and the trigemino-cardiac reflex (N = 7; information component = 10.36 (95% confidence interval: 9.06 - 11.21)) for midazolam, propofol, and dexmedetomidine, respectively. The Standardized Regulatory Activities Medical Dictionary Analysis Queries with the strongest signal across all sedatives were torsade de pointes and shock-associated conditions (N = 679; information component = 4.24 (95% confidence interval: 4.12 - 4.34)).
CONCLUSION: These findings highlight the need for clinicians to consider cardiovascular toxicity when administering sedatives in the intensive care unit, as different sedatives exhibit different adverse reaction profiles.