Skip to Content

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.

See references

Hydroxychloroquine Breastfeeding Warnings

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

See references

References for pregnancy information

  1. Costedoat-Chalumeau N, Amoura Z, Duhaut P, et al. "Safety of hydroxychloroquine in pregnant patients with connective tissue diseases: A study of one hundred thirty-three cases compared with a control group." Arthritis Rheum 48 (2003): 3207-11
  2. "Product Information. Plaquenil (R). (hydroxychloroquine)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  3. "Drugs for rheumatoid arthritis." Treat Guidel Med Lett 7 (2009): 37-46
  4. Costedoat-Chalumeau N, Amoura Z, Aymard G, et al. "Evidence of transplacental passage of hydroxychloroquine in humans." Arthritis Rheum 46 (2002): 1123-4

References for breastfeeding information

  1. "Product Information. Plaquenil (R). (hydroxychloroquine)." Sanofi Winthrop Pharmaceuticals, New York, NY.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.