Difelikefalin-associated adverse drug event signals: a real-world pharmacovigilance study from the FAERS database - PubMed
4 hours ago
- #hemodialysis
- #pharmacovigilance
- #neuropsychiatric safety
- The study aimed to identify adverse drug event (ADE) signals associated with difelikefalin, a drug for chronic kidney disease-associated pruritus in hemodialysis patients, using the FAERS database.
- Disproportionality analyses of 328 reports showed the strongest signals for Nervous system disorders (ROR=3.4) and Psychiatric disorders (ROR=2.99) at the System Organ Class level.
- Key high-risk signals at the Preferred Term level included mental status changes, disorientation, electric shock sensation, somnolence, fall, and fracture.
- Elderly patients (aged 65+ years) were identified as a high-risk group, with male patients more commonly reported.
- The findings suggest a need for targeted clinical monitoring, especially for neuropsychiatric events, and validation through prospective cohort studies.