Disproportionate adverse event signals of selumetinib in neurofibromatosis type I: insights from FAERS.

ABSTRACT:

Background

Neurofibromatosis type 1 (NF1) is a rare neurogenetic disorder with limited treatment options. Selumetinib, a MEK1/2 inhibitor, has emerged as a promising therapy for inoperable NF1-related plexiform neurofibromas.

Methods

Our retrospective pharmacovigilance study utilized the FDA Adverse Event Reporting System (FAERS) to comprehensively evaluate Selumetinib's safety profile in real-world settings. Data from the third quarter of 2020 to the fourth quarter of 2023 were analyzed, identifying 498 adverse event reports with Selumetinib as the primary suspect drug.

Results

Statistical analysis revealed disproportionate signals for skin and subcutaneous tissue disorders, eye disorders, and various congenital, familial, and genetic disorders. The most common adver

SUBMITTER: Li L 

PROVIDER: S-EPMC11747384 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature