Candesartan Pregnancy and Breastfeeding Warnings

Candesartan is also known as: Atacand

Candesartan Pregnancy Warnings

Candesartan has been assigned to pregnancy category D by the FDA. Animal data have revealed reduced survival and increased incidence of hydronephrosis in the offspring, as well as maternal toxicity. There are no controlled studies in human pregnancy, however, postmarketing experience has identified incidents of fetal and neonatal toxicity in babies born to women treated with candesartan during their pregnancy. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of candesartan is considered contraindicated during pregnancy.

Candesartan is similar to angiotensin converting enzyme (ACE) inhibitors, which are contraindicated during pregnancy. Because of the many reports of fetal deaths and malformations associated with the use of ACE inhibitors, a committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. Drugs that act on the renin-angiotensin-aldosterone (RAA) system can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature in patients who were taking ACE inhibitors. The use of drugs that act directly on the RAA 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 been reported, although it is not clear whether these occurrences were due to exposure to the drug. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester; however first trimester use of ACE inhibitors, a specific class of drugs acting on the renin angiotensin system, was associated with a potential risk of birth defects. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist, such as eprosartan, only during the first trimester should be informed. Rarely (probably less than once in every thousand pregnancies), no alternative to a drug acting on the RAA system will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment. If oligohydramnios is observed, candesartan should be discontinued unless it is considered lifesaving for the mother. Contraction stress testing (CST), a nonstress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. However, patients and physicians should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants with histories of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.

Candesartan Breastfeeding Warnings

There are no data on the excretion of candesartan into human milk. 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.

Animal studies have shown candesartan to be present in breast milk.

See Also...

• Candesartan use while Breastfeeding (in more detail)
• candesartan Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

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