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Quinine Pregnancy and Breastfeeding Warnings

Quinine is also known as: QM-260, Qualaquin

Quinine Pregnancy Warnings

Quinine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Congenital abnormalities (including damage to the auditory and optic nerve) have been reported following the use of large doses of quinine for its abortifacient effect. Quinine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Quinine crosses the placenta and gives measurable blood concentrations in the fetus. In 8 women who delivered live infants 1 to 6 days after starting quinine therapy, placental cord plasma quinine levels were between 1.0 and 4.6 mg/L and the ratio of cord plasma to maternal plasma quinine levels averaged 0.32. During a study of women with Plasmodium falciparum malaria, difference in the rate of stillbirths at greater than 28 weeks of gestation was not significant in pregnant women treated with quinine compared to a control group without malaria or exposure to antimalarial agents during pregnancy. The overall rate of congenital malformations was not different for women treated with quinine (1.4%) compared with the control group (1.7%). The rate of spontaneous abortion was lower in women treated with quinine (3.5%) than in the control group (10.9%). In an epidemiologic survey, risk of structural birth defects was not increased in 104 mother-child pairs exposed to quinine during the first 4 months of pregnancy. Two fetal malformations (1.9%) were reported. Teratogenic effects were observed in 21 infants exposed to quinine during the first trimester following unsuccessful abortion attempts. These effects included central nervous system, digestive organ, urogenital, and vertebral anomalies; limb, facial, and heart defects; and hernias. Neonatal and maternal thrombocytopenia purpura and hemolysis in glucose-6-phosphate dehydrogenase-deficient newborns have been reported with quinine use. The Michigan Medicaid Birth Defects Study included 35 newborns exposed to quinine during the first trimester. Two (5.7%) major birth defects were observed; 1 was expected. There were no observations of cardiovascular defects, cleft palate, spina bifida, polydactyly, limb reduction, or hypospadias. Briggs, et al has assigned Risk Factor D to quinine. Although increased teratogenic risk has not been proven, avoiding quinine use during pregnancy has been recommended. A manufacturer of a formerly available quinine product considered it contraindicated in pregnancy. There is no evidence that quinine causes uterine contractions at the doses recommended to treat malaria. In doses several times higher than those used to treat malaria, quinine may stimulate the pregnant uterus.

Quinine Breastfeeding Warnings

Quinine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely, but the diagnosis of glucose-6-phosphate dehydrogenase deficiency should be ruled out before breast-feeding. Quinine is considered compatible with breast-feeding by the American Academy of Pediatrics.

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