The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation

BackgroundSuzetrigine (Journavx; VX-548), the first selective NaV1.8 voltage-gated sodium channel inhibitor approved by the FDA on 30 January 2025, represents a novel non-opioid option for moderate-to-severe acute pain. Given its recent market entry and unique peripheral mechanism, comprehensive post-marketing safety surveillance is essential.ObjectiveThis study aimed to identify and characterize adverse event signals associated with suzetrigine in the FDA Adverse Event Reporting System (FAERS)