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Hydroxychloroquine Pregnancy and Breastfeeding Warnings

Hydroxychloroquine is also known as: Plaquenil, Quineprox

Hydroxychloroquine Pregnancy Warnings

Animal studies have revealed evidence of fetal harm. Use of chloroquine and other 4-aminoquinolines in high doses and for prolonged durations has been associated with neurological disturbances and interference with hearing, balance, and vision in the fetus. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

UK: Contraindicated
AU, US: Use should be avoided except in the suppression or treatment of malaria the judgment of the physician the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Animal studies show that this drug passes rapidly across the placenta. It accumulated selectively in the melanin structures of the fetal eyes and was retained in the ocular tissues for 5 months after the drug had been eliminated from the rest of the body.

Comments:
-Use of this drug during pregnancy should be avoided except in the suppression or treatment of malaria.
-This drug crosses the placenta.
-Therapeutic doses of 4-aminoquinolines have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation.

See references

Hydroxychloroquine Breastfeeding Warnings

Some experts do not recommend breastfeeding during therapy with this drug. Infants exposed to this drug during breastfeeding receive only small amounts of the drug. In a small number of infants up to at least 1 year of age, careful follow-up found no adverse effects on growth, vision, or hearing.

AU, UK: Benefit should outweigh risk.
US: Data not available

Excreted into human milk: Yes

Comments:
-Infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

See references

References for pregnancy information

  1. "Product Information. Hydroxychloroquine Sulfate (hydroxychloroquine)." Prasco Laboratories, Cincinnati, OH.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Hydroxychloroquine Sulfate (hydroxychloroquine)." Prasco Laboratories, Cincinnati, OH.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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