Pharmacovigilance study of BCR-ABL1 tyrosine kinase inhibitors: A safety analysis of the FDA Adverse Event Reporting System

Abstract

Abstract Background With the increased use of BCR-ABL1 tyrosine kinase inhibitors (TKIs) in cancer patients, adverse events (AEs) have garnered considerable interest. We conducted this pharmacovigilance study by using the Food and Drug Administration Adverse Event Reporting System (FAERS) database to evaluated the AEs of BCR-ABL1 TKIs in cancer patients. Methods We used OpenVigil 2.1 to query AE reports from the FAERS database. Descriptive analysis was used to describe the characteristics of TKIs-associated AE reports. Disproportionality analysis was used to detect safety signals by calculating proportional reporting ratio (PRR) and reporting odds ratios (ROR). Results A total of 85989 AE reports were retrieved from the FAERS database and 3080 significant AE signals were identified. The numbers of significant AE signals for imatinib, nilotinib, dasatinib, bosutinib, and ponatinib were 1058, 813, 232, 186, and 791 respectively. The significant signals were divided into 26 system organ classes (SOCs). The AE signals of imatinib and ponatinib were mainly fixed on general disorders and administration site conditions, while the AE signals of nilotinib, dasatinib, and bosutinib were mainly fixed on investigations, respiratory, thoracic and mediastinal disorders, and gastrointestinal disorders, respectively. Of note, 245, 278, 47, 55, 253 unexpected signals were observed in imatinib, nilotinib, dasatinib, bosutinib and ponatinib, respectively. Conclusions The results of the present study are compatible with clinical experience. The study showed that AE signals were differ among the five BCR‐ABL1 TKIs. Moreover, several unexpected signals were observed in each BCR‐ABL1 TKI. These findings provide valuable information for clinicians to reduce the risk of adverse drug reactions during the BCR‐ABL1 TKIs treatment.