Hydroxyurea Exposure in Lactation: a Pharmacokinetics Study (HELPS)

J Pediatr. 2020 Jul:222:236-239. doi: 10.1016/j.jpeds.2020.02.002. Epub 2020 Mar 11.


Lactation is contraindicated for women with sickle cell anemia receiving hydroxyurea therapy, despite sparse pharmacokinetics data. In 16 women who were lactating volunteers, we documented hydroxyurea transferred into breastmilk with a relative infant dosage of 3.4%, which is below the recommended 5%-10% safety threshold. Breastfeeding should be permitted for women taking daily oral hydroxyurea.

Keywords: breastfeeding; hydroxyurea; pharmacokinetics; sickle cell anemia.

Publication types

  • Case Reports
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anemia, Sickle Cell / drug therapy*
  • Anemia, Sickle Cell / metabolism
  • Antineoplastic Agents / pharmacokinetics
  • Antisickling Agents
  • Female
  • Humans
  • Hydroxyurea / pharmacokinetics*
  • Lactation / drug effects*
  • Milk, Human / drug effects
  • Milk, Human / metabolism*


  • Antineoplastic Agents
  • Antisickling Agents
  • Hydroxyurea