Kidney Week

Abstract: TH-PO911

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

Session Information

• Anemia and Iron Metabolism
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• 200 Anemia and Iron Metabolism

Authors

• Bell, Abraham, Florida State University, Tallahassee, Florida, United States

Abraham Bell, DO

• Maddineni, Gautam, Florida State University, Tallahassee, Florida, United States

Gautam Maddineni, MD

• Milutinovic, Stefan, Florida State University, Tallahassee, Florida, United States

Stefan Milutinovic, MD

• Bell, Isaac, Nova Southeastern University, Fort Lauderdale, Florida, United States

Isaac Bell, DO

• Oliveira, Meloney, Florida State University, Tallahassee, Florida, United States

Meloney Oliveira, MD

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)