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Hydroxychloroquine Pregnancy and Breastfeeding Warnings

Hydroxychloroquine is also known as: Plaquenil, Quineprox

Hydroxychloroquine Pregnancy Warnings

A case study of eleven pregnant women treated with hydroxychloroquine 200 mg either twice or once daily for at least 6 months reported that at delivery, the levels of hydroxychloroquine in cord blood were strongly correlated with hydroxychloroquine concentrations in maternal blood (p=0.01 by Spearman test). One hundred thirty-three consecutive pregnancies in 90 women treated with 200 mg of hydroxychloroquine either twice daily (122 pregnancies) or once daily (11 pregnancies) were studied. These pregnancies were compared to 70 consecutive pregnancies in 53 women with similar disorders who did not receive study medication. Electrocardiography was performed in 47 children of mothers treated with hydroxychloroquine and in 45 children in the control subjects. The results showed 88% of pregnancies in the hydroxychloroquine group compared to 84% in the control group ended successfully with a live birth. The outcomes of pregnancy were not statistically different between groups.

Hydroxychloroquine has not been formally assigned to a pregnancy category by the FDA. Animal studies have revealed that the drug passed rapidly across the placenta, accumulated selectively in the melanin structures of the fetal eyes, and was retained in the ocular tissues for five months after the drug had been eliminated from the rest of the body. There are no controlled data in human pregnancy. However, the findings of one study have shown preliminary safety support for the use of hydroxychloroquine during pregnancy. The only situation in which hydroxychloroquine is recommended for use during pregnancy is in the suppression or treatment of malaria, when in the judgment of the physician, the benefits outweigh the risks.

Hydroxychloroquine Breastfeeding Warnings

There are no data on the excretion of hydroxychloroquine into human milk.

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