Safety of artemisinin and non-artemisinin antimalarials in the first trimester of pregnancy

Malaria in pregnancy is a significant health problem in malaria-endemic areas. It not only causes substantial childhood morbidity and mortality but also increases the risks of adverse events for pregnant women and their developing fetuses. Most of the burden in these areas is due to infection with Plasmodium falciparum. Artemisinin-based combination therapy (ACT) has been recommended as first-line treatment for uncomplicated P. falciparum malaria in all populations, including pregnant women in their second and third trimesters, since 2006. However, for women in their first trimester of pregnancy, WHO recommended as first-line treatment a combination of quinine and clindamycin.

Based on a review of the evidence conducted in 2022, WHO now recommends artemether–lumefantrine, the ACT with the most human safety data available, as the preferred treatment for uncomplicated P. falciparum malaria in the first trimester of pregnancy. This document presents all relevant evidence on the effects and safety in early pregnancy of artemisinins and partner medicines used in ACTs from both studies in experimental animals and observational studies in humans.