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Drug-induced perioperative malignant hyperthermia: a real-world study based on the Food and Drug Administration
Zeguang Lu1, Minghai Huang2, Liying Liu1
1Department of Anesthesiology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
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.
Insights
Malignant hyperthermia (MH) is a serious adverse drug reaction during surgery. This study analyzed drug-related MH cases from 2005-2024, identifying key triggers and trends to improve patient safety.
Area of Science:
- Anesthesiology and Perioperative Medicine
- Pharmacovigilance and Drug Safety
- Critical Care Medicine
Background:
- Malignant hyperthermia (MH) is a known, severe adverse drug reaction (ADR) linked to specific anesthetic agents.
- A comprehensive, up-to-date profile of drugs potentially triggering perioperative MH is currently lacking.
- Understanding these triggers is crucial for preventing severe patient outcomes during surgery.
Purpose of the Study:
- To comprehensively profile drugs associated with perioperative malignant hyperthermia (MH) using a large adverse event database.
- To identify and quantify the risk signals of specific drugs implicated in MH events, including fatal outcomes.
- To analyze trends in MH reports over time and inform patient safety strategies.
Main Methods:
- Utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) database for reports from Q1 2005 to Q4 2024.
- Collected and analyzed adverse event (AE) reports related to perioperative MH and fatal MH outcomes.
- Applied disproportionality analysis to identify significant drug-related MH signals and classify risk levels.
Main Results:
- A total of 769 perioperative MH cases were reported, with 100 (13%) resulting in fatalities.
- Out of 26 identified drugs, 17 showed positive MH signals via disproportionality analysis.
- Inhalation anesthetics were most frequently reported, followed by muscle relaxants; sevoflurane, isoflurane, propofol, succinylcholine, and fentanyl were top triggers. Muscle relaxant-associated MH reports showed an increasing trend.
Conclusions:
- This study offers a detailed overview of drug-induced perioperative MH, highlighting the need for ongoing vigilance and personalized risk assessment.
- Findings validate known MH triggers and reveal evolving risk patterns, emphasizing the importance of updated safety protocols.
- Actionable strategies are proposed to enhance patient safety and guide future research in anesthesiology, based on FAERS data analysis.
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