Objective: To analyze the adverse event signals of inhaled anesthesia drug sevoflurane based on the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS).
Methods: Adverse event reports with sevoflurane as the primary suspected drug were collected from the FAERS database across 77 quarterly periods from 2004 to 2023. The disproportionate analysis method was used to evaluate the risk magnitude and occurrence characteristics of various adverse events associated with sevoflurane.
Results: A total of 2 861 sevoflurane adverse event reports were extracted, and 266 adverse event signals of sevoflurane were obtained, involving 20 system organ classes. Among them, 17 adverse event signals, including cardiac arrest, pulmonary oedema, pulmonary alveolar haemorrhage, etc., were not included in the drug instructions. Sevoflurane adverse event occurred mainly within 24 hours after drug administration and showed gender differences. Seven adverse event signals, including pulmonary alveolar haemorrhage, nephrogenic diabetes insipidus, cardiac arrest, etc., were stronger in male patients. Whereas the abnormal liver function test abnormal, oliguria, hypersensitivity, drug ineffective and other eight adverse event signals were relatively stronger in female patients.
Conclusion: The adverse events of sevoflurane can involve multiple system organs and differ across genders, which should be considered in clinical practice to provide individualized treatment. |
