Frontiers in pharmacology
Post-marketing safety signal profile of mavacamten in the FDA adverse event reporting system (FAERS): a disproportionality analysis
By Wu J, Chen C and Zheng T.
Abstract
Background
Mavacamten is a first-in-class cardiac myosin inhibitor approved for symptomatic obstructive hypertrophic cardiomyopathy; however, its risk of reduced left ventricular ejection fraction and systolic heart failure warrants post-marketing safety evaluation.
Methods
FAERS quarterly open data from 2022 Q2 to 2025 Q2 (13 quarters) were retrospectively analyzed. After global deduplication, mavacamten reports were identified using "MAVACAMTEN" or "CAMZYOS" as primary or secondary suspect drugs. Disproportionality was assessed by the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM). A positive primary signal required at least 3 reports, a lower bound of the ROR 95% confidence interval (CI) greater than 1, and IC025 greater than 0; PRR and EBGM served as consistency measures only. Sensitivity analyses included count-threshold analyses and an exploratory covariate-adjusted ROR (aROR) analysis.
