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Telmisartan Pregnancy and Breastfeeding Warnings

Telmisartan is also known as: Micardis

Telmisartan 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, telmisartan 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. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist, such as telmisartan, only during the first trimester should be informed. Nonetheless, when a patient becomes pregnant, it is strongly recommended that physicians discontinue the use of telmisartan as soon as possible.

Telmisartan has been assigned to pregnancy category D by the FDA. Animal data have failed to reveal evidence of teratogenicity. However, embryotoxicity (reduced viability, low birth weight, delayed maturation, and decreased weight gain) and embryolethality associated with maternal toxicity (reduced body weight gain and food consumption) were observed after daily doses of ranging from 15 to 45 mg/kg/day (approximately 7 times the maximum recommended human dose). Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of telmisartan is considered contraindicated during pregnancy.

Telmisartan Breastfeeding Warnings

There are no data on the excretion of telmisartan into human milk, but telmisartan was shown to be present in the milk of lactating rats. The manufacturer recommends that due to the potential for serious adverse effects in the nursing infant, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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