Quinidine Pregnancy and Breastfeeding Warnings
Quinidine Pregnancy Warnings
Quinidine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Quinidine should be given during pregnancy only when benefit outweighs risk.
Quinidine crosses the placenta, with umbilical cord blood to maternal serum concentration ratios ranging from 0.2 to 0.8. Quinidine, when compared to many other cardiovascular drugs, is considered relatively safe for the fetus. Quinidine has been used successfully and safely to treat resistant fetal tachyarrhythmias and to treat acute malaria in pregnant women. Neonatal thrombocytopenia has been reported after maternal ingestion of quinidine. Data from the Michigan Medicaid Birth Defects Study has failed to reveal an association between quinidine and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 17 were exposed to quinidine at some time during the first trimester, and 68 were exposed to the drug at any time during pregnancy. Of these pregnancies, a single birth defect was observed. This observation did not achieve statistical significance. There were no observations of cardiovascular defects, cleft palate, spina bifida, polydactyly, limb reduction, or hypospadias. These data do not support an association between quinidine and birth defects.
Quinidine Breastfeeding Warnings
Quinidine is excreted into human milk. The manufacturer reports that quinidine is present in human milk at levels slightly lower than those in maternal serum. The effects in the nursing infant is unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
References for breastfeeding information
- "Product Information. Quinidex (quinidine)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
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