Journal Article

Signal Mining and Analysis of Drug-Induced Myelosuppression: A Real-World Study From FAERS

Xia, Kaiyue, Zeng, Yingjian, Chen, Shupeng, Tang, Nana, Zhang, Meiling

2025

Overview

Introduction Drug-induced myelosuppression (DIM) is a serious side effect of several medications, particularly chemotherapy, immunosuppressants, and targeted therapies, which can lead to infections, anemia, and bleeding. While these drugs are effective, their adverse effects can disrupt treatment plans and reduce quality of life. However, early identification of DIM remains challenging, as many associated drugs do not explicitly list this risk, complicating clinical monitoring. Methods This study utilized the FDA Adverse Event Reporting System (FAERS) database to perform signal mining and assess the risks of DIM. Reports from the first quarter of 2004 to the third quarter of 2024 were analyzed using signal detection algorithms such as Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). These methods helped identify drug signals related to DIM and explore risk factors and occurrence patterns. Results The study analyzed 21 380 adverse event reports related to DIM, showing a significant increase in the number of reports since 2019, peaking at 3501 in 2021. Among patients, 50.2% were female, 35.5% were male, and the majority (44.42%) were aged between 18 and 65. Breast cancer patients had the highest DIM incidence (10.6%). Geographically, China reported the most cases (57.4%), followed by Japan (12.4%), and the United States (6.76%). The drugs most frequently linked to DIM included trastuzumab, bevacizumab, venetoclax, methotrexate, and pertuzumab. Additionally, 12 new drug signals were identified that were not labeled for DIM risk, including PERTUZUMAB, SODIUM CHLORIDE, and MESNA, which showed particularly strong or unexpected associations. Conclusion This study identifies new DIM-related drug signals and emphasizes the need for early detection to improve clinical management and optimize treatment regimens. The findings provide valuable evidence for drug safety monitoring and can help reduce DIM-related risks in cancer treatment. Plain Language Summary Drug-induced myelosuppression (DIM) is a condition where certain medications cause a decrease in blood cells, which can lead to serious health problems like infections, anemia, and bleeding. This is especially a concern for cancer patients who are treated with chemotherapy, targeted therapies, and immunotherapy. However, it is often difficult to predict which drugs might cause this side effect, especially once the drugs are already on the market. In this study, we used real-world data from the FDA’s Adverse Event Reporting System (FAERS) to find out which drugs are most likely to cause DIM. By analyzing over 21,000 reports from patients between 2004 and 2024, we identified several drugs that are strongly linked to DIM, including some that hadn’t been officially labeled for this risk. Our findings help improve the understanding of DIM, allowing doctors to better monitor patients and reduce the chances of severe complications. This research provides important information that can help doctors choose safer treatment options for cancer patients, and it can also guide regulatory agencies in improving drug safety warnings.

• Publisher: SAGE Publications,Sage Publications Ltd,SAGE Publishing
• Subject: Adolescent / Adult / Adverse Drug Reaction Reporting Systems - statistics & numerical data / Adverse events / Aged / Anemia / Antineoplastic Agents - adverse effects / Bayes Theorem / Bayesian analysis / Bevacizumab / Bleeding / Blood cells / Cancer therapies / Chemotherapy / Data Mining - methods / Databases, Factual / Drug-Related Side Effects and Adverse Reactions - epidemiology / Drugs / Female / Humans / Immunosuppressive agents / Immunotherapy / Male / Methotrexate / Middle Aged / Myelosuppression / Neural networks / Patients / Pharmacovigilance / Product safety / Quality of life / Risk Factors / Side effects / Trastuzumab / United States - epidemiology / United States Food and Drug Administration / Young Adult