Postmarketing Safety of Irinotecan and Association with Pharmacogenomic Studies: a Pharmacovigilance Study Based on FDA Adverse Event Reporting System (FAERS)

In this study, we aimed to conduct a descriptive research based on FAERS, to comprehensively evaluate the post-marketing safety of irinotecan, and the impact of pharmacogenomics studies on it. We accessed all available reports from the FAERS public dashboard. Taking irinotecan, UGT1A1, and SLCO1B1 as keywords, searched all literatures in PubMed. A total of 18,294 cases were included in the final analysis. The 60-69 age group has the largest number of ADRs, Myelosuppression accounted for the largest proportion (17.60%), followed by diarrhea (12.82%). 17,933 cases (98.03%) are serious, and 3,293 (18.23%) led to death. The total and death ADRs began to decrease after 2018 (APC = -26.25) and 2014 (APC = -8.19), respectively. The pharmacogenetic studies ushered rapid growthand during 1998-2006, then remained relatively high (APC = -0.12). With the development of pharmacogenomics, the ADRs caused by irinotecan showed a downward trend, indicating the importance of personalized medicine.