Can I take hydroxychloroquine while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data) . There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations). Animal reproduction studies were not conducted with hydroxychloroquine. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Hydroxychloroquine Sulfate (oral), Bryant Ranch Prepack. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Infants exposed to hydroxychloroquine during breastfeeding receive only small amounts of the drug in breastmilk. In infants up to at least 1 year of age, careful follow-up found no adverse effects on growth, vision or hearing.[1–3] International professional guidelines have stated that the drug is a low risk to the nursing infant and acceptable to use during breastfeeding.[4–6]

When given once weekly for malaria prophylaxis, the amount of drug is not sufficient to harm the infant nor is the quantity sufficient to protect the child from malaria. Breastfeeding infants should receive the recommended dosages of hydroxychloroquine for malaria prophylaxis.[7]

“Summary of Use during Lactation”, LactMed record “Hydroxychloroquine” (LM290), quoted verbatim. Everything LactMed reports about Hydroxychloroquine while breastfeeding.

8.2 Lactation Risk Summary Published lactation data report that hydroxychloroquine is present in human milk at low levels. No adverse reactions have been reported in breastfed infants. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk. There is no information on the effect of hydroxychloroquine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for hydroxychloroquine sulfate and any potential adverse effects on the breastfed child from hydroxychloroquine sulfate or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: Hydroxychloroquine Sulfate (oral), Bryant Ranch Prepack. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.