Safety of Hydroxyurea in Pregnancy: A Systematic Review of the Literature
ABSTRACT
Objective: Hydroxyurea (HU) is an antimetabolite drug used to
manage several hematologic conditions, including chronic myeloid
leukemia and sickle cell disease (SCD). Animal studies and limited
human data have raised concern that HU exposures in pregnancy
may increase the risk of congenital malformations or abnormal fetal
growth. Although the quality of evidence is low, it has been
recommended that HU is discontinued at least 3 months before
conception.
Data Sources: We systematically reviewed all published studies up to
July 2024 describing pregnancy and neonatal outcomes after HU
exposure during pregnancy.
Study Selection: A total of 329 articles went through title and abstract
screening, which resulted in 54 articles undergoing full-text review,
and 15 articles were finally eligible for data extraction. These 15
studies included in the review, published between 1993 and 2023,
comprised 7227 pregnancies, with 567 pregnancies (7.8%)
exposed to HU. Patient ages ranged from 17 to 45 years. Most
patients had SCD (n . 502), followed by chronic myeloid leukemia
(n . 26), essential thrombocythemia (n . 24), and chronic myeloid
splenomegaly (n . 2). In 13 cases, the underlying disease was not
specified. The timing of exposures to HU varied from conception
until throughout pregnancy. Neither teratogenic nor
ABSTRACT
Objective: Hydroxyurea (HU) is an antimetabolite drug used to
manage several hematologic conditions, including chronic myeloid
leukemia…