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Post-marketing pharmacovigilance study of gilteritinib and midostaurin from the FAERS database
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| Key learnings |
| A total of 46 safety signals were identified for midostaurin and 53 for gilteritinib. |
| The common AEs of both drugs were in line with findings from clinical trials. Midostaurin was most frequently associated with nausea, vomiting, diarrhea, pyrexia, and febrile neutropenia, while gilteritinib was associated with febrile neutropenia, pyrexia, anemia, and thrombocytopenia. |
| Both drugs produced unexpected AEs not listed on the label. Midostaurin exhibited 24 signals, including neutropenic colitis, neutropenic sepsis, septic shock, and hepatotoxicity. Gilteritinib exhibited 29 signals, including septic shock, neutropenic sepsis, cerebral hemorrhage, subdural hematoma, tumor lysis syndrome, and interstitial lung disease. |
| Limitations of the spontaneous report database, including reporting bias, lack of causal relationship between the drug and the AE, inability to calculate incidence and severity of AEs, and other confounding factors, highlight the need for further studies to validate the findings. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; FAERS, Food and Drug Administration Adverse Event Reporting System; R/R, relapsed/refractory.
- Jiang T, Li Y, Zhang N, et al. Unveiling unexpected adverse events: post-marketing safety surveillance of gilteritinib and midostaurin from the FDA Adverse Event Reporting database. Ther Adv Drug Saf. 2025;16: DOI: 10.1177/20420986241308089
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