Polythiazide Pregnancy and Breastfeeding Warnings
Polythiazide is also known as: Renese
Polythiazide Pregnancy Warnings
Polythiazide has been assigned to pregnancy category C by the FDA. Animal data have failed to reveal evidence of teratogenicity associated with thiazides, but the data are considered limited in some cases because visceral or skeletal abnormalities were not sought. There are no controlled data in human pregnancy. Some retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Polythiazide should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related 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 communication, 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.
Polythiazide Breastfeeding Warnings
While there are no data on polythiazide, many other thiazide diuretic agents are known to be excreted into human milk in low concentrations. Although a rare case of thrombocytopenia has been reported in one nursing infant whose mother was taking chlorothiazide, adverse effects in nursing infants are unlikely. However, 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 pregnancy information
- Pritchard JA, Walley PJ "Severe hypokalemia due to prolonged administration of chlorothiazide during pregnancy." Am J Obstet Gynecol 81 (1961): 1241-4
- Prescott LF "Neonatal thrombocytopenia and thiazide drugs." J Pediatr 67 (1965): 681-2
- Minkowitz S, Soloway HB, Hall JE, Yermakov V "Fatal hemorrhagic pancreatitis following chlorothiazide administration in pregnancy." Obstet Gynecol 24 (1964): 337-42
References for breastfeeding information
- Miller ME, Cohn RD, Burghart PH "Hydrochlorothiazide disposition in a mother and her breast-fed infant." J Pediatr 101 (1982): 789-91
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