Polythiazide / reserpine Pregnancy and Breastfeeding Warnings

Brand names: Renese-R

Polythiazide / reserpine Pregnancy Warnings

Reserpine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity after doses 125 to 250 times the maximum recommended human dose (MRHD, on a per kg basis) were given to rats. Abnormalities included anophthalmia, absence of the axial skeleton, and hydronephrosis. Pregnancy in rabbits was interrupted when doses 10 times the MRHD were given early or late in pregnancy. There are no controlled data from human pregnancy studies. Reserpine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Polythiazide has been assigned to pregnancy category C by the FDA. Animal data have failed to reveal evidence of teratogenicity associated with thiazide-type diuretics, but the data are considered limited in some cases because visceral or skeletal abnormalities were not sought. There are no controlled data from human pregnancy studies. Some retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Use of polythiazide during pregnancy in patients without heart disease is considered contraindicated by some experts. Polythiazide should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

There are three relevant sources of information regarding the use of reserpine during human pregnancy: a case report and two retrospective studies.

In one case report, a stillborn female was born at gestation week 30 to a hypertensive, 30-year-old mother who had taken reserpine from days 13 to 41. Abnormalities included cleft lip and palate and bilateral anophthalmia, marked scoliosis, a thoracolumbar open defect, and diaphragmatic agenesis. The mother had also been exposed to tobacco and ampicillin.

Cziezel summarized the Hungarian experience with reserpine from 1980 to 1984. During this period, 52 of 6,227 pregnant women were exposed to reserpine. Neither the total group nor subgroups of congenital anomalies indicated a significant increase associated with reserpine treatment during pregnancy. There was no evidence of a congenital reserpine syndrome.

Of 50,282 mother-child pairs monitored by the Collaborative Perinatal Project, 48 had first trimester exposure to reserpine and 475 had exposure to reserpine at anytime during pregnancy. Of the 48, four defects (8%) were observed, which was more than expected. Of the 475, microcephaly (7), hydronephrosis (3), inguinal hernia (12), and hydroureter (3) were observed. None of these anomalies occurred significantly more than expected.

In the same study, of the 50,282 mother child pairs, 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 make 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 reserpine or thiazide diuretics and congenital defects (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). Of 229,101 completed pregnancies between 1985 and 1992, 15 were exposed to reserpine at some time during the first trimester, and 42 were exposed to the drug at any time during pregnancy. No birth defects were observed. Regarding thiazide diuretics, this report is a summary of 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 either reserpine or 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.

See references

Polythiazide / reserpine Breastfeeding Warnings

Reserpine is excreted into human milk. There are no reports of adverse effects on the nursing infant. There is a report of galactorrhea associated with reserpine.

While there are no data on polythiazide, many other thiazide diuretic agents are known to be excreted into human milk in low concentrations. While a rare case of thrombocytopenia has been reported in one nursing infant whose mother was taking chlorothiazide, adverse effects in the nursing infant are unlikely. Although some thiazides such as chlorothiazide are considered compatible with breast-feeding by the American Academy of Pediatrics, some manufacturers recommend 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.

See references

Further information

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