Skip to Content

Artemether / lumefantrine Pregnancy and Breastfeeding Warnings

Artemether / lumefantrine is also known as: Coartem

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.

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.