Post-marketing safety evaluation of anthracycline for acute myeloid leukemia treatment: a real-world pharmacovigilance analysis.

BACKGROUND

Anthracyclines are key for acute myeloid leukemia (AML) but carry serious side effects. This study identifies their side effects across drugs and patient populations using the FDA Adverse Event Reporting System (FAERS).

MATERIALS AND

METHODS

We analyzed 1,079 AML cases and 3,622 adverse events (AEs) from FAERS (2004-2024). Disproportionality analyses (PRR, ROR, BCPNN, MGPS) detected AE signals; Kruskal-Wallis tests evaluated time-to-onset by age/sex.

RESULTS

Distinct risks emerged: epirubicin (strongest cardiotoxicity, ROR = 10.57), doxorubicin (highest pregnancy-related AEs, ROR = 9.97), daunorubicin (vascular disorders, ROR = 2.38), idarubicin (myelosuppression/infections). Most AEs occurred within 180 days. Idarubicin showed delayed onset in elderly (P < 0.05); males had delayed doxorubicin toxicity (P = 0.04) but accelerated idarubicin onset (P = 0.049) vs. females.

CONCLUSION

This analysis identifies distinct safety profiles. Epirubicin and doxorubicin were associated with cardiac and pregnancy-related risks, while idarubicin showed signals suggesting potentially delayed onset in elderly patients. Observed sex differences indicate possible variations in AE patterns.