The safety of the combination artesunate and pyrimethamine-sulfadoxine given during pregnancy

Malaria during pregnancy is associated with an increased risk of severe ana emia and low-birthweight babies. Effective intermittent therapy with pyrime thamine-sulfadoxine (PSD) decreases parasitaemia and severe anaemia and imp roves birthweight in areas where Plasmodium falciparum is sensitive to this drug. Increasing resistance to PSD is a concern and alternative antimalari al regimens during pregnancy are needed. Artesunate with PSD is a promising antimalarial combination but few data are available on the safety of artem isinins when taken during pregnancy. Outcome of pregnancy was evaluated for 287 women in The Gambia who were exposed in June 1999 to a single dose of the combination artesunate and PSD during a mass drug administration and 17 2 women who were not exposed. Women who received placebo (40) and those who did not participate in the mass drug administration (132) comprised the no n-exposed group. There was no difference in the proportion of abortions, st illbirths, or infant deaths among those exposed or not exposed to the drugs . The mean weight of 18 infants born to mothers who had received artesunate and PSD during the third trimester was 3.10 kg compared to a mean weight o f 2.62 kg of the 10 infants of untreated mothers (adjusted P value = 0.05). We found no evidence of a teratogenic or otherwise harmful effect of gesta tional exposure to artesunate and PSD. Treatment of a self-selected group o f pregnant women with PSD and artesunate during pregnancy was associated wi th a greater birthweight, which may have resulted from clearance of malaria parasites. However, the influence of confounding factors cannot be exclude d.