(P-215) Safety Profile Analysis of Sunitinib and Dasatinib Protein Kinase Inhibitors Using FDA Adverse Event Reporting System (FAERS) Database

Background: Some critical adverse events are associated with the use of both Dasatinib and Sunitinib. They are contributed to discontinuation of therapeutic treatment.

Objectives: To describe the most commonly reported adverse events (AEs) related to Sunitinib and Dasatinib as reported in the FDA Adverse Event Reporting System (FAERS) and to summarize patients’ demographics involved in the AE’s reports.

Methods: The primary data source was the publicly available FAERS database. The study design was a retrospective descriptive time-series study from quarter 1, 2012 to quarter 1, 2020. Number of AEs and patient cases were calculated for both study drug brand names and generics. The annual number of AE reports, demographics and most frequently reported AEs were identified. Descriptive statistics was used to describe the trend and pattern of adverse events and number of cases over time.

Results: The total number of AEs reports was (22271) for Dasatinib and (24602) for Sunitinib for study period. Mean age (SD) for involved patients was 53.3(5.3) for Dasatinib and 63.8(4.4) for Sunitinib. Gender proportions were as the following for Dasatinib; 41.49% female, 40.79% male and 17.26% unknown. For Sunitinib, gender proportions were; 25.49% female, 47.725 male and 26.34 unknown. The most common Dasatinib adverse events included pleural effusion, fatigue, nausea and diarrhea. For Sunitinib, the most common adverse events were death, fatigue, decreased appetite, nausea and hypertension.

Conclusions: Therapeutic risk management is crucial for both Dasatinib and Sunitinib, since they are considered as targeted therapies in cancer treatment plan. Further studies are warranted to establish a causal relationship between drug and adverse events.