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Potassium citrate Pregnancy and Breastfeeding Warnings

Potassium citrate is also known as: Twin-K, Urocit-K

Potassium citrate Pregnancy Warnings

Potassium citrate is a naturally-occurring molecule. If K+ products are necessary in a pregnant patient, close attention to the maternal serum K+ concentrations is recommended due to the risk of maternal and fetal cardiac arrhythmias associated with abnormal serum K+ concentrations. Data from the Michigan Medicaid Birth Defects Study, in which 104,339 deliveries between 1980 to 1983 and 229,101 deliveries between 1985 to 1992 were retrospectively studied, reveal conflicting data (written communication, Frank Rosa, MD, Food and Drug Administration, 1994). In these two studies, 116 and 166 women, respectively, were exposed to a related molecule, potassium chloride (KCl), during gestation. Of the 116 women from the 1980 to 1983 period, 14 defects were observed (7 were expected), of which 4 were cardiovascular abnormalities (1 was expected). These data are consistent with an association between KCl and birth defects. Of the 166 women from the 1985 to 1992 period, 8 defects were observed (7 were expected). There were no cases of cardiovascular abnormalities. There were no cases of cleft palate from either period studied. These data do not provide evidence of an association between KCl and birth defects.

Potassium citrate has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Some experts consider potassium replacement to be indicated and relatively safe for pregnant women. Potassium citrate is only recommended for use during pregnancy when benefit outweighs risk.

Potassium citrate Breastfeeding Warnings

The normal potassium ion content of human milk is about 13 mEq/L. It is not known if potassium citrate has an effect on this content. Potassium citrate should be given to a nursing woman only if clearly needed.

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