Follow-up of infants exposed to hydroxychloroquine given to mothers during pregnancy and lactation

J Perinatol. 2005 Feb;25(2):86-9. doi: 10.1038/


Objective: To determine the effect of hydroxychloroquine treatment during pregnancy and lactation on babies of mothers affected by rheumatic diseases.

Study design and methods: A total of 40 infants born from mothers affected by rheumatic diseases and treated with hydroxychloroquine during pregnancy were enrolled in a prospective observational study. Main outcome measures at birth were incidence of prematurity, congenital malformations and neonatal infections. Of these babies, including 13 who were breast-fed, 24 were followed up during early infancy for visual function and neurodevelopmental outcome.

Results: Preterm delivery was the main complication (20.5%). No significant congenital malformations or neonatal infections were detected. All infants, including those who were breast-fed, had normal visual function and neurodevelopmental outcome.

Conclusions: Hydroxychloroquine treatment during gestation and lactation appeared to be safe. The relatively high incidence of preterm deliveries may reflect the maternal disease state.

MeSH terms

  • Antirheumatic Agents / adverse effects*
  • Antirheumatic Agents / therapeutic use
  • Breast Feeding*
  • Child Development / drug effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Hydroxychloroquine / adverse effects*
  • Hydroxychloroquine / therapeutic use
  • Infant, Newborn
  • Male
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Premature Birth / etiology
  • Rheumatic Diseases / complications
  • Rheumatic Diseases / drug therapy*


  • Antirheumatic Agents
  • Hydroxychloroquine