A Real-World Pharmacovigilance study of FAERS Database for Fluvoxamine: Perspectives from Physicians and Pharmacists.

Abstract

Background: Fluvoxamine is a well-established treatment for depressive disorders. However, real-world safety data regarding fluvoxamine remains limited. This study aims to analyze adverse drug events (ADEs) associated with fluvoxamine using the large-scale pharmacovigilance database FAERS, to assess its safety profile.

Methods: The FAERS database was used to collect data on ADEs related to fluvoxamine from the first quarter of 2004 to the third quarter of 2024. Disproportionality analyses were performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM) methods.

Result: A total of 355 ADEs reports related to fluvoxamine were identified, spanning 26 different System Organ Classes (SOCs) and 67 preferred terms (PTs). Psychiatric disorders were the most frequently reported ADEs. Notably, signals for reproductive system and breast disorders, cardiac disorders, and eye disorders were stronger but not related to the pharmacological properties of fluvoxamine, thus warranting special clinical attention. Disinhibition showed the highest signal strength in fluvoxamine and requires vigilance. A considerable number of drug interactions were noted, leading to increased antipsychotic drug levels and extrapyramidal symptoms, such as slow speech, drooling, and tardive dyskinesia. Self-harm and suicidal behavior necessitate clinical risk management. Additionally, significant symptoms of serotonin syndrome were observed, including tic, clonus, mydriasis, and myoclonus. Our study also uncovered ADEs not previously documented in product labels, such as Cushing's syndrome, papilloedema, and increased intracranial pressure.

Conclusion: This study provides a real-world pharmacovigilance analysis of fluvoxamine. It identifies several rare ADEs and clinically significant symptoms, particularly neuroleptic malignant syndrome and serotonin syndrome. Our study offers important insights for the clinical safety assessment of fluvoxamine.