Journal of pain research · 2025
Desflurane Safety Revisited: A Pharmacovigilance Study Detecting Potential Safety Signals from FAERS Data.
СтатьяНазвание и аннотация: Перевод в очереди
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Wei Wei, Chen Liang, Ying Xiaomei
Аннотация
PURPOSE: Desflurane is a widely used volatile anesthetic with multiple clinical advantages, but comprehensive pharmacovigilance analyses are needed to optimize its safety profile. This study aimed to analyze and classify adverse events(AEs) associated with desflurane in the Food and Drug Administration Adverse Event Reporting System(FAERS) database and evaluate potential safety signals.
PATIENTS AND METHODS: We analyzed FAERS reports from 2004Q1 to 2025Q1 where desflurane was the primary suspect(PS) drug. Cases were classified using Medical Dictionary for Regulatory Activities (MedDRA27.1) terminology and processed following FDA-recommended deduplication strategy. Four disproportionality analyses were conducted: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
RESULTS: Among 1,191 cases, bradycardia was most frequent (n = 39; ROR = 38.72, 95% CI 28.14-53.28) with 79.4% classified as serious. Notable findings included anaphylactic shock (n = 23; 69.6% serious), bronchospasm (n = 22), and malignant hyperthermia(MH) (n = 20; 25% mortality). Acute respiratory distress syndrome (ARDS) (n = 2) and disseminated intravascular coagulation (DIC) (n = 2) were documented - a previously unreported association with desflurane exposure.
CONCLUSION: Our analysis reveals clinically significant safety signals associated with desflurane, including cardiovascular, anaphylactic, and respiratory complications that may require enhanced perioperative monitoring. The study underscores the critical importance of sustained post-marketing surveillance for detecting rare but serious safety signals, not typically evident in pre-approval clinical trials.
PATIENTS AND METHODS: We analyzed FAERS reports from 2004Q1 to 2025Q1 where desflurane was the primary suspect(PS) drug. Cases were classified using Medical Dictionary for Regulatory Activities (MedDRA27.1) terminology and processed following FDA-recommended deduplication strategy. Four disproportionality analyses were conducted: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
RESULTS: Among 1,191 cases, bradycardia was most frequent (n = 39; ROR = 38.72, 95% CI 28.14-53.28) with 79.4% classified as serious. Notable findings included anaphylactic shock (n = 23; 69.6% serious), bronchospasm (n = 22), and malignant hyperthermia(MH) (n = 20; 25% mortality). Acute respiratory distress syndrome (ARDS) (n = 2) and disseminated intravascular coagulation (DIC) (n = 2) were documented - a previously unreported association with desflurane exposure.
CONCLUSION: Our analysis reveals clinically significant safety signals associated with desflurane, including cardiovascular, anaphylactic, and respiratory complications that may require enhanced perioperative monitoring. The study underscores the critical importance of sustained post-marketing surveillance for detecting rare but serious safety signals, not typically evident in pre-approval clinical trials.