The Effects of Inadvertent Exposure of Mefloquine Chemoprophylaxis on Pregnancy Outcomes and Infants of US Army Servicewomen

During US military operations in Somalia, mefloquine, a drug for malaria chemoprophylaxis, was not approved for use in pregnant women. Some female soldiers inadvertently used mefloquine before becoming aware of their pregnancy. A registry was established to follow the outcomes of these pregnancies. Questionnaires were administered at the time the pregnancy was diagnosed, after termination or delivery, and at 1 year after birth. Seventy-two soldiers were eligible for the registry. There were 17 elective abortions, 12 spontaneous abortions, 1 molar pregnancy, and 23 live births. The outcome for 19 soldiers was unknown. An unexpected high rate of spontaneous abortions was observed. All infants were healthy at birth, with no major congenital malformations. One infant died at 4 months of viral pneumonitis. At 1 year of age, 13 infants were reported to be healthy, with normal cognitive and motor development. This study provides additional postmarketing data that mefloquine does not cause gross congenital malformations.