Risk of bronchospasm and coronary arteriospasm with sugammadex use: a post marketing analysis.
Introduction: Sugammadex is used for the reversal of neuromuscular blockade caused by rocuronium bromide and vecuronium bromide. As part of the post licensing phase of drug development, adverse events related to the use of sugammadex are still being uncovered and being reported. The potential association between sugammadex and adverse events bronchospasm and coronary arteriospasm using a retrospective pharmacovigilance signal analysis was carried out.
Methods: Food and Drug Administration's Adverse Event Reporting System database was used to run disproportionality analyses to investigate the potential association of sugammadex with bronchospasm or coronary arteriospasm. In this analysis we report the adverse event signal using frequentist methods of Relative reporting ratio (RRR), proportional reporting ratio (PRR), reporting odds ratio (ROR) and the Bayesian based Information Component metric.
Results: A statistically significant disproportionality signal is found between sugammadex and bronchospasm (n = 44; chi-squared = 2993.87; PRR = 71.95 [95% CI: 54.00-95.85]) and sugammadex and coronary arteriospasm (n = 6; chi-squared = 209.39; PRR = 43.82 [95% CI: 19.73-97.33]) as per Evans criteria. Both statistically significant disproportionality signals persisted when stratified by gender. Based upon dynamic cumulative PRR graph, the PRR value has steadily increased and the 95% CI narrowed since December 2012.
Conclusion: The results of the pharmacovigilance analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex. The results of the pharmacovigilance signal analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex.
|ジャーナル名||Therapeutic advances in drug safety|
|組織名||University of Cincinnati College of Medicine, 2545 Dennis Street Apt 7105,;Cincinnati, Ohio, USA.|