A Real-World Pharmacovigilance Study of the FDA Adverse Event Reporting System Events for Trametinib.

ABSTRACT

OBJECTIVE: This research investigates adverse drug events (ADEs) linked to trametinib, utilizing data from the FDA Adverse Event Reporting System (FAERS) database, covering the period from Q2 2013 to Q4 2023. METHODS: We gathered data on ADEs associated with trametinib from the second quarter of 2013 to the fourth quarter of 2023. After standardizing the data, we applied various analytical methods to quantify signals, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation for Neural Networks (BCPNN), and multi-item gamma Poisson shrinker (MGPS). RESULTS: In our examination of 2200 ADE reports with trametinib cited as the primary suspect, we identified 191 adverse reaction terms across 23 system organ classifications. The most frequently reported classifications were general disorders and administration site conditions, with 1254 cases (ROR 0.83, PRR 0.85, IC -0.23, EBGM 0.85), followed by neoplasms (benign, malignant, and unspecified, including cysts and polyps) with 802 cases (ROR 3.59, PRR 3.32, IC 1.73, EBGM 3.32), and investigations with 794 cases (ROR 1.74, PRR 1.66, IC 0.73, EBGM 1.66). Notably, this study also uncovered previously unlabeled adverse reactions such as cheilitis, lobular panniculitis, ulcerative keratitis, and stridor. CONCLUSION: While trametinib provides therapeutic advantages, it is associated with several potential adverse reactions. It is crucial for healthcare providers to closely monitor patients for symptoms such as cheilitis, lobular panniculitis, ulcerative keratitis, stridor, and other adverse events (AEs) during treatment.