Micardis Use In Pregnancy & Lactation

The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy and should not be initiated during pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy.
Non-clinical studies with telmisartan do not indicate teratogenic effects, but have shown fetotoxicity.
When used in pregnancy during the second and third trimerters, drug that act direcly on the renin-angiotensin system can cause injury and even death to the developing fetus. When preganncy is detected, micardis tablets should be discontinued as soon as possible.
Drug that act directly on the renin-angiotensin 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 angiotensin coverting enzyme inhibitors. When pregnancy is detected, Micardis tablets should be discountinued as soon as possible. The use of drug that act directly on the renin-angiotensin system during 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, presumbaly resulting from decreased fetal renal fiction: 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 accurrences were due to exposure to the drug.
Angiotensin II receptor antagonists exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension. MICARDIS is contraindicated during lactation since it is not known whether it is excreted in human milk. Non-clinical studies have shown excretion of telmisartan in breast milk.
Fertility: No studies on fertility in humans have been performed.
In non-clinical studies, an effect of MICARDIS on male and female fertility was not observed.