Hydroxyurea is classified as an S-phase antineoplastic agent (pregnancy cat
egory D). Two women became pregnant while taking hydroxyurea for sickle cel
l anemia and delivered live infants with no congenital anomalies. Although
teratogenic effects of hydroxyurea were reported in animal studies, several
case reports suggest the agent :may have minimal teratogenic effects on th
e developing fetus. Fourteen cases of hydroxyurea therapy in pregnant patie
nts with acute or chronic myelogenous leukemia, primary thrombocythemia, or
sickle cell disease are reported in the literature. Three pregnancies were
terminated by elective abortion; one woman developed eclampsia and deliver
ed a phenotypically normal stillborn infant. All other patients delivered l
ive, healthy infants without congenital anomalies. Further studies with lar
ger numbers; of patients receiving hydroxyurea during pregnancy, with longe
r follow-up of exposed children and more careful assessment of fetotoxic ef
fects, are required before the agent can be promoted as safe in pregnancy.