Artemisinin and its derivatives (artesunate, artemether, dihydroartemisinin) are used in the treatment of malaria, usually in combination with other antimalarials, which is termed artemisinin-based combination therapy (ACT). In the UK the only licensed artemisinin derivative is artemether (in combination with lumefantrine).
Artemisinins have been associated with embryolethality in animal studies, therefore theoretical concerns regarding use in humans exist. However, human data do not provide evidence of an increased risk of miscarriage following exposure to artemisinin and its derivatives during pregnancy.
The available human data do not currently provide any reliable evidence indicating that first trimester artemisinin use is associated with an increased risk of malformation. However, the data are highly limited which precludes the ability to provide an informed assessment of the risk. A large number of second and third trimester pregnancy exposures have been documented which do not signal that gestational exposure to artemisinin or its derivatives is associated with increased rates of stillbirth, low birth weight or preterm delivery above those observed in women treated with other antimalarials.
Untreated or inadequately treated maternal malaria infection poses a serious risk to both the mother and the fetus, therefore treatment with artemisinin or artemisinin derivatives should not be withheld at any stage of pregnancy if considered essential for maternal treatment. The UK malaria treatment guidelines (2016) and WHO guidelines for the treatment of malaria (2015) state that uncomplicated falciparum malaria should be treated with artemether-lumefantrine in the second and third trimester, and with quinine and clindamycin in the first trimester. Women with severe malaria in any trimester of pregnancy should be treated the same as non-pregnant patients, with artesunate preferred over quinine. Specialist advice should be sought regarding treatment of malaria during pregnancy.
Exposure to artemisinin and derivatives of the compound at any stage in pregnancy in the absence of maternal malaria infection would not usually be regarded as medical grounds for additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Discussion with UKTIS is recommended in all cases.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.