Aliskiren / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Aliskiren / hydrochlorothiazide is also known as: Tekturna HCT

Aliskiren / hydrochlorothiazide Pregnancy Warnings

Drugs that act directly on the renin-angiotensin-aldosterone (RAA) 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 similar drugs, 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, aliskiren should be discontinued as soon as possible. The use of drugs that act directly on the RAA system during the second and third trimesters 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 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. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. 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. 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 hydrochlorothiazide (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 underlying disease(s) of the mother are not accounted for. Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported.

Aliskiren-hydrochlorothiazide has been assigned to pregnancy category D by the FDA. Animal studies with aliskiren have failed to reveal evidence of teratogenicity. However, fetal birth weight was affected after daily doses of 50 mg/kg/day (approximately 3.2 times the maximum recommended human dose). There are no controlled data regarding use of hydrochlorothiazide in human pregnancy, but retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of aliskiren-hydrochlorothiazide is considered contraindicated during pregnancy.

Aliskiren / hydrochlorothiazide Breastfeeding Warnings

There are no data on the excretion of aliskiren into human milk, but it is excreted in the milk of lactating rats. Hydrochlorothiazide 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 mother.

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