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Artemether / lumefantrine Pregnancy and Breastfeeding Warnings

Artemether / lumefantrine is also known as: Coartem

Medically reviewed by Last updated on Jan 10, 2018.

Artemether / lumefantrine Pregnancy Warnings

Artemether-lumefantrine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryo-fetal loss and fetal defects. Safety data from an observational pregnancy study of approximately 500 pregnant women who were exposed to artemether-lumefantrine (including a third exposed during the first trimester), and published data of over 1000 pregnant patients who were exposed to artemisinin derivatives, did not show an increase in adverse pregnancy outcomes or teratogenic effects over background rate. Artemether-lumefantrine is only recommended for use during pregnancy when benefit outweighs risk.

See references

Artemether / lumefantrine Breastfeeding Warnings

There are no data on the excretion of artemether or lumefantrine into human milk; however, animal data suggest both artemether and lumefantrine are excreted into breast milk. The effects in the nursing infant are unknown. The manufacturer recommends that caution be used when administering artemether-lumefantrine to nursing women.

See references

References for pregnancy information

  1. "Product Information. Coartem (artemether-lumefantrine)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. McGready R, Tan SO, Ashley EA, et al. "A randomised controlled trial of artemether-lumefantrine versus artesunate for uncomplicated plasmodium falciparum treatment in pregnancy." PLoS Med 5 (2008): e253
  3. Stover KR, King ST, Robinson J "Artemether-lumefantrine: an option for malaria." Ann Pharmacother 46 (2012): 567-77

References for breastfeeding information

  1. "Product Information. Coartem (artemether-lumefantrine)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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