Table 3 Safety outcomes: maternal adverse events and pregnancy outcomes in women exposed to artemisinin compounds: Descriptive studies.

China, 1976–1980 [15]

Artemisinin IM or Artemether

No adverse effect

6 (100%) followed up at 5–9 year

None

TBB, 1992–2000 [16]

Artesunate alone or with mefloquine; clindamycin atovaquone-proguanil; coartemether, artemether IM

No ADRs (pruritus)

Maternal deaths (n = 2)*

Abortions 4.8% (n = 20)

Stillbirth 1.8% (n = 7)

Congenital abnormalities 0.8%: anencephaly (n = 1); midline epidermoid cyst (n = 1)

Abortions 23% (n = 10)

TBB 1999–2001 [19]

Artesunate+atovaquone-proguanil

Symptoms possible ADRs: Headache (42%); muscle/joint pain (30%); abdominal pain (42%); anorexia (40%); nausea (25%); vomiting (10%); rash (15%); dizziness (70%), tinnitus (24%); contraction (15%) and sleep disturbance (8%)

Neonatal deaths (n = 1)

Normal deliveries and healthy newborns

Gambia, 1999 [41]

Artesunate + SP

Maternal deaths (n = 1)**

Stillbirth (n = 11)

Congenital abnormalities: umbilical hernia (n = 1); undescended testis; (n = 1) Neonatal deaths (n = 8)

Not reported

Sudan, 1997–2001 [22]

Artemether IM

NR

Neonatal deaths (n = 1)

Normal delivery and healthy newborn

Sudan, 2004–2005 [23]

Artesunate + SP

Giddiness and nausea (13%)

Neurological exam.

Neonatal deaths (n = 1)

None

TOTAL

123 1 ^st trimester, P. falciparum or mixed malaria 7% to 100% symptomatic 945 artemisinin exposures

3 maternal deaths

Neurological exam in 2 studies

Abortions n = 20

Stillbirths (n = 18)

Congenital abnormality: (n = 4) Neonatal deaths (n = 11)

65 (15%) infant followed up to 1 year

Abortions n = 10