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Hydroflumethiazide Pregnancy and Breastfeeding Warnings

Hydroflumethiazide is also known as: Diucardin, Saluron

Hydroflumethiazide Pregnancy Warnings

Hydroflumethiazide has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been performed. There are no controlled data from human pregnancy. Some retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Hydroflumethiazide should only be given during pregnancy when there are no alternatives and benefits outweighs risk.

Thiazide diuretics readily cross the human placenta, with umbilical cord blood thiazide levels approximately equivalent to maternal plasma thiazide levels. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics, although the fact that the population studied had underlying cardiovascular disease makes implication of drug use alone difficult. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labor. The Michigan Medicaid surveillance study showed no association between some thiazide diuretics and congenital defects (written communications, Franz Rosa, MD, Food and Drug Administration, 1994). This report is a summary of information from two studies, one in which 390 of 104,000 pregnant women from 1980 to 1983, and one in which 567 of 229,000 pregnant women from 1985 to 1992 received a related drug, hydrochlorothiazide (HCTZ). In the first study 28 total defects and 6 cardiovascular defects were observed (25 and 4 were expected, respectively). In the second study, 24 total defects and 7 cardiovascular defects were observed (22 and 6 were expected, respectively). Cleft palate was not observed in either study. These data do not support an association between HCTZ and congenital defects, and are considered pertinent to other thiazide diuretics. Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported.

Hydroflumethiazide Breastfeeding Warnings

Thiazide diuretics are excreted into human milk in low concentrations. While a rare case of thrombocytopenia has been reported in one nursing infant whose mother was taking a related drug, chlorothiazide, adverse effects in the nursing infant are unlikely. The manufacturer recommends caution when administering hydroflumethiazide to nursing women.

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