Drug-induced perioperative malignant hyperthermia: a real-world study based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

BACKGROUND

Perioperative malignant hyperthermia (MH) remains an established adverse drug reaction (ADR) for certain drug classes, but the comprehensive profile of current potential MH-triggering drugs is still lacking.

METHODS

The adverse event (AE) reports related to perioperative MH in the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2005 to the fourth quarter of 2024 were collected to count and trend the drugs associated with perioperative MH or perioperative MH with fatal outcomes. The disproportionality analysis was applied to identify ADR signals for each drug, classifying drugs in regard to perioperative MH, and determining risk levels.

RESULTS

From 2005 to 2024, there were 769 perioperative MH cases reported in FAERS, of which 100 (13.00%) were reported as perioperative MH with fatal outcomes. Of the 26 distinct drugs determined in the FAERS database that were related to perioperative MH, 17 were considered to have positive signals according to disproportionality analysis. In all classes, the inhalation anesthetics had the most frequently reported number of perioperative MH, followed by muscle relaxants, general anesthetics and opioid anesthetics. For specific pharmacological drugs, the top five single drugs with the largest reported number were sevoflurane (26.79), isoflurane (25.88%), propofol (9.62%), succinylcholine (6.63%), and fentanyl (4.68%). Linear regression demonstrated that the number of perioperative MH and perioperative MH death reports caused by muscle relaxants continued to increase during the study period.

CONCLUSION

This study provided a comprehensive landscape of the drug-induced perioperative MH, emphasizing continued vigilance, individualized risk assessment. This study provides comprehensive insights into drug-induced perioperative MH, validating known triggers while identifying evolving risk patterns. By contextualizing FAERS data within clinical and pharmacological frameworks, we highlight actionable strategies to enhance patient safety and guide future research in this critical area of anesthesiology.