Melanosis Secondary to Drugs: A Real-World Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

[BACKGROUND] Melanosis is an acquired hyperpigmentation disorder that can be associated with the use of medications; timely identification and discontinuation of relevant medications is an important aspect of clinical management.

[OBJECTIVE] This study investigates the relationship between melanosis and drug exposure based on data from the FDA Adverse Event Reporting System (FAERS) database. We sought to determine the top drugs reported in association with melanosis in the FAERS.

[METHODS] A retrospective analysis of FAERS data from January 2004 to June 2024 was conducted to identify reports related to melanosis, using the Comprehensive Medical Dictionary for Regulatory Activities (MedDRA) terminology. A total of 18 182 912 independent adverse event reports were processed, and signal mining analyses were performed to detect associations between drugs and melanosis. Disproportionality analyses were conducted using four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The most frequently reported drugs and their associated adverse event reports were analyzed.

[RESULTS] Hundred and one reports related to melanosis were screened, involving 73 drug names as primary suspect (PS). By combining and organizing the different names of drugs such as trade names and generic names, 66 drugs were obtained. The top five drugs associated with melanosis were talimogene laherparepvec (ROR: 1891.39), followed by ferrous sulfate (ROR: 997.14), minocycline (ROR: 176.05), vemurafenib (ROR: 97.64), and pembrolizumab (ROR: 19.73).

[CONCLUSION] Patients who experience drug-induced melanosis generally have bad outcomes, underscoring the imperative for heightened clinical surveillance regarding the risk of drug-induced melanosis.