Eprosartan / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Brand names: Teveten HCT

Eprosartan / hydrochlorothiazide Pregnancy Warnings

Eprosartan-hydrochlorothiazide has been assigned to pregnancy category D by the FDA. Eprosartan, alone or in combination with hydrochlorothiazide, has been shown to produce maternal and fetal toxicities (maternal and fetal mortality, low maternal body weight and food consumption, resorptions, abortions and litter loss) in pregnant rabbits. There are no controlled data in human pregnancy. The manufacturer states that when used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. Retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Use of eprosartan-hydrochlorothiazide during pregnancy is considered contraindicated.

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme (ACE) inhibitors. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. When pregnancy is detected or expected, eprosartan-HCTZ should be discontinued as soon as possible.

The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the use of these drugs.

Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be informed of the potential risks to the fetus. When patients become pregnant, physicians should have the patient discontinue the use of eprosartan-HCTZ as soon as possible.

There are significant warnings against the use of thiazides during pregnancy. 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 those who took thiazide diuretics. 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.

Data from the Michigan Medicaid Birth Defects Study has revealed an association between the use of HCTZ 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 567 were exposed to HCTZ at some time during the first trimester and 1,173 were exposed to the drug at any time during pregnancy. Of the 567 pregnancies, there were 24 total and 7 cardiovascular birth defects (22 and 6 were expected, respectively). There were no observations of cleft palate, spina bifida, limb reduction, or hypospadias. The one instance of polydactyly did not achieve statistical significance. These data are consistent with an association between the use of HCTZ and birth defects, although other factors, including any underlying disease(s) of the mother were not accounted for.

Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported.

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Eprosartan / hydrochlorothiazide Breastfeeding Warnings

There are no data on the excretion of eprosartan into human milk. Hydrochlorothiazide (HCTZ) is secreted into human milk in low concentrations. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the nursing mother.

In one case, a peak milk HCTZ concentration of 125 ng/mL was measured between 4 and 12 hours after a (usual daily) dose of HCTZ 50 mg in one subject. A simultaneously measured maternal serum HCTZ level was approximately 275 ng per mL. There were no detectable drug levels or electrolyte abnormalities in the baby's blood. The authors calculated that, if a 1-month-old infant takes approximately 600 mL of milk per day, and the average milk HCTZ level is approximately 80 ng per mL, the infant would be exposed to approximately 0.05 mg HCTZ a day. This usually represents an insignificant amount of HCTZ to the infant such that adverse effects in the nursing infant are unlikely with regard to this component of this combination drug.

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