A real-world analysis of safety profile of selexipag by using FDA adverse Event Reporting System (FAERS)

Abstract

ABSTRACTBackgroundThe current investigation sought to conduct a real-world analysis of adverse events (AEs) associated with selexipag by utilizing data from the Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsThe Reporting Odds Ratios (ROR) and the Medicines Healthcare Products Regulatory Agency (MHRA) method were employed to assess the potential associations between selexipag and AEs. Case reports of adverse drug reaction (ADR) related to selexipag were systematically sourced from PubMed, Embase, and Web of Science databases.ResultsOur analysis identified 281 Preferred Terms (PTs) signals across 20 System Organ Classes (SOCs) were found to meet the screening threshold. The most common AEs were consistent with instructions, randomized controlled trials (RCTs), and case reports. Of significant note, unexpected AEs principally target SOCs of infections and infestations, blood and lymphatic system, renal and urinary disorders, hepatobiliary disorders, including pneumonia, metapneumovirus, decreased hemoglobin. transfusion, iron-deficiency anemia, dialysis hypotension, abnormal creatinine renal clearance, liver function test increased, hepatic function abnormal, hepatic enzyme increased. Within the pediatric population, unexpected signals such as pyrexia, pneumonia, and intussusception necessitate special precautionary measures.ConclusionsThe findings contribute valuable insights to clinical practice, reinforcing the importance of vigilant monitoring, and can be instrumental in guiding both therapeutic applications and safety assessments of this particular medication.