Poly (ADP-ribose) polymerase inhibitor-associated myelodysplastic syndrome/acute myeloid leukemia: a pharmacovigilance analysis of the FAERS database

Z Ma, XM Sun, WC Lu, ZX Zhao, ZM Xu, JY Lyu… - ESMO …, 2021 - esmoopen.com
The US Food and Drug Administration (FDA) warned that poly (ADP-ribose) polymerase
(PARP) inhibitors may induce myelodysplastic syndromes (MDSs) and acute myeloid
leukemia (AML) in the label. The supporting data were mostly from clinical trials with a low
incidence of 0.5%-1.4%.