Cardiac disorder-related adverse events for aryl hydrocarbon receptor agonists: a safety review.

BACKGROUND

Although cardiac disorder-related adverse events (AEs) have been reported in patients treated with aryl hydrocarbon receptor (AHR) agonists, their safety profiles remain unknown. Here, we identified significant cardiac disorders associated with AHR agonists and further evaluated their relevance.

RESEARCH DESIGN AND METHODS

Database queries were performed using OpenVigil 2.1 and AEs voluntarily submitted to Food and Drug Administration Adverse Event Reporting System (FAERS) between 2004 and 2020 were included. This study based on the Medical Dictionary for Regulatory Activities and the standardized MedDRA Queries to define the preferred terms, and we used reporting odd ratio to detect signals.

RESULTS

In the FAERS database, 14,078 cardiac disorder-related AEs were identified in patients receiving AHR agonists. Among all AHR agonists, the number of cardiac disorder-related PTs with positive signals for AHR agonists was 93. Peripheral swelling (n = 1572) and atrial fibrillation (n = 1277) were the most reported cardiac disorder-related AEs among AHR agonists in disproportionately reported PTs. Moreover, several AHR agonists were highly associated with tachyarrhythmia.

CONCLUSIONS

By mining the FAERS database, we provided more information on the association between AHR agonist use and cardiac disorder-related AEs.