pharmacovigilance

BackgroundAnthracyclines are key for acute myeloid leukemia (AML) but carry serious side effects. This study identifies their side effects across drugs and patient populations using the FDA Adverse Event Reporting System (FAERS).Materials and methodsWe analyzed 1,079 AML cases and 3,622 adverse events (AEs) from FAERS (2004–2024). Disproportionality analyses (PRR, ROR, BCPNN, MGPS) detected AE si…

BackgroundElagolix and Myfembree are gonadotropin-releasing hormone (GnRH)-pathway therapies used for endometriosis, but their post-marketing safety reporting patterns remain incompletely characterized. Because spontaneous reporting databases are susceptible to reporting bias and differential market exposure, comparative analyses require cautious interpretation.MethodsWe analyzed quarterly data f…

BackgroundMirogabalin, a novel third-generation α2-δ calcium channel ligand, is approved for diabetic peripheral neuropathic pain (DPNP). However, its post-marketing safety profile remains insufficiently characterized, particularly regarding novel signals and comparative safety profiles with established therapies.ObjectivesThis study aimed to identify and characterize adverse event (AE) signals a…

BackgroundMosunetuzumab is a CD20×CD3 bispecific antibody approved for adult relapsed or refractory follicular lymphoma. Post-marketing evidence on its safety profile remains scarce. This pharmacovigilance study used the Food and Drug Administration Adverse Event Reporting System (FAERS)to characterize real-world adverse event (AE) signals associated with mosunetuzumab.MethodsWe performed disprop…

ObjectiveTo characterize the spectrum, strength, and cross-database reproducibility of peripheral nervous system (PNS) safety signals associated with antibody–drug conjugates (ADCs), and to examine discrepancies between post-marketing pharmacovigilance signals and current regulatory labeling.MethodsA multi-database pharmacovigilance study was conducted using spontaneous adverse event reports from…

ObjectiveUsing malignant neoplasm/tumour progression as the endpoint, we screened FAERS for disproportionate reporting signals, characterized the drug spectrum represented in progression-related reports, and prioritized drug–event pairs for further evaluation rather than causal inference.MethodsPublicly available reports from FAERS (2004Q1–2024Q4) and JADER (2004–2024) were analyzed. After FDA-re…