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Use in Pregnancy ACE inhibitors can cause fetal and neonatal morbidity and mortality when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, PRINIVIL ® should be discontinued as soon as possible. In rare cases (probably less than once in every thousand pregnancies) in which no alternative to ACE inhibitor therapy will be found, the mothers should be apprised of the potential hazards to their fetuses.
Serial ultrasound examinations should be performed to assess fetal development and well-being and the volume of amniotic fluid. Text Continues Below
If oligohydramnios is observed, PRINIVIL ® should be discontinued unless it is considered life saving for the mother. A non-stress test (NST), and/ or a biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. If concerns regarding fetal well-being still persist, a contraction stress testing (CST) should be considered. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants with a history of in utero exposure to ACE inhibitors 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 a means of reversing hypotension and/ or substituting for impaired renal function, however, experience with those procedures has been limited. Lisinopril has been removed from the neonatal circulation by peritoneal dialysis with some clinical benefit and may, theoretically be removed by exchange transfusion, although there is no experience with the latter procedure. Human Data It is not known whether exposure limited to the first trimester of pregnancy can adversely affect fetal outcome. The use of ACE inhibitors 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. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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