Pregnancy-Related Adverse Events with Tyrosine Kinase Inhibitor Use in Chronic Myeloid Leukemia: A FAERS Pharmacovigilance Analysis (2001-2024).

[BACKGROUND] Tyrosine kinase inhibitors (TKIs) are essential therapies for chronic myeloid leukemia (CML), yet their safety during pregnancy remains poorly characterized. We aimed to address this gap by providing pharmacovigilance data using the FDA Adverse Event Reporting System (FAERS).

[METHODS] We conducted a comprehensive pharmacovigilance analysis of pregnancy-related adverse events (AEs) reported to FAERS between January 2001 and December 2024. Reports involving female patients exposed to imatinib, dasatinib, nilotinib, ponatinib, bosutinib, or asciminib were extracted. Pregnancy-related AEs were categorized into maternal and fetal outcomes and presented descriptively. Disproportionality analyses were also performed for 2022-2024 to determine only the more relevant AEs in contemporary clinical practice. Reporting odds ratios (RORs) with 95% confidence intervals (CI) were used to quantify associations.

[RESULTS] A total of 651 relevant pregnancy-related AEs were identified between 2001 and 2024, with imatinib accounting for the majority (n = 450), followed by nilotinib (n = 118), dasatinib (n = 64), ponatinib (n = 13), bosutinib (n = 4), and asciminib (n = 2). The most frequently reported maternal AEs were abortion (40.6%) and polyhydramnios (4.3%), while the most frequent perinatal complications included premature delivery (33.6%) and low birth weight (4.4%). In the disproportionality analysis (2022-2024), imatinib was significantly associated with pregnancy-related AEs (ROR 3.47; 95% CI: 1.49-8.05).

[CONCLUSION] This pharmacovigilance analysis suggests a signal of pregnancy-related adverse events with imatinib, while evidence for other TKIs remains limited. Given the paucity of data, results should be interpreted with caution. Larger studies are needed to confirm these findings.