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Candesartan Pregnancy and Breastfeeding Warnings

Candesartan is also known as: Atacand

Candesartan Pregnancy Warnings

FDA pregnancy category: D Use of candesartan is not recommended. Women of child bearing potential should be encouraged to use adequate contraception.

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. 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. Postmarketing experience has identified incidents of fetal and neonatal toxicity in babies born to women treated with candesartan during their 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. 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. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Candesartan Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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