Malignant melanoma and multiple sclerosis therapies: A disproportionality analysis of the FDA adverse event reporting system.

Publication date: Jun 25, 2025

Despite nationwide cohort studies revealing an increased risk of malignant melanoma (MM) in people with multiple sclerosis (PwMS), the connection between MS disease-modifying therapies (DMTs) and MM risk remains underexplored. We identified 1200 reports of MM associated with MS DMTs in the FDA Adverse Event Reporting System (FAERS), and a pooled analysis of all DMTs showed disproportionately high MM reporting compared to all other FAERS medications (reporting odds ratio, 2. 30; 95% confidence interval, 2. 16-2. 45; χ, 702. 33). As MS DMTs may influence MM risk, clinicians should educate PwMS on the importance of regular skin self-examinations.

Concepts Keywords
Clinicians disease-modifying therapies
Fda Multiple sclerosis
Increased
Sclerosis

Semantics

Type Source Name
disease MESH Malignant melanoma
disease MESH multiple sclerosis

Original Article

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