Pharmacovigilance Analysis of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Events for Daprodustat

Background: Daprodustat was granted approval by the U.S. Food and Drug Administration on February 1st, 2023, marking it as the inaugural oral therapy for anemia induced by chronic kidney disease in adult patients undergoing dialysis for a minimum of four months. Notably, daprodustat carries a black box warning due to the heightened risk of thrombotic vascular events, myocardial infarction, cerebral vascular events, and mortality. Methods: The adverse events associated with daprodustat were examined by utilizing the FDA Adverse Event Reporting System (FAERS). Our analysis encompassed data spanning from February 2023 to March 31st, 2024. Results: A comprehensive review of 575 reported cases revealed that 318 cases necessitated hospitalization due to the severity of the adverse effects, with 147 reported fatalities. Notably, the most frequently reported event among hospitalized patients was a reduction in hemoglobin levels subsequent to the initiation of daprodustat (37 cases). The second most commonly reported event was cardiac failure, encompassing both new onset and acute exacerbation of chronic heart failure (35 cases). Additionally, venous thromboembolism (VTE) was reported in 15 cases. Conclusion: FAERS analysis has highlighted anemia, acute exacerbation of heart failure, and venous thromboembolism as noteworthy adverse effects associated with daprodustat. Given its status as a novel medication, it is imperative to conduct further research and implement vigilant monitoring whilst on treatment with daprodustat.FAERS Adverse event proflie amongst hospitalizations (severe cases)