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Environmental Assessment

Adverse Pregnancy Outcomes Associated with Maternal Enalapril Antihypertensive Treatment

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Enalapril, one of several antihypertensive drugs that act as angiotensin-converting enzyme (ACE) inhibitors, is often used for treatment of hypertension in women of reproductive age. Adverse birth outcomes following the use of ACE inhibitors, including enalapril, during pregnancy have been reported in case histories and descriptive studies. In this article, enalapril exposures beyond the first trimester of pregnancy are associated with pre- and postnatal developmental disorders, such as reduced amniotic fluid volume (oligohydramnios), intrauterine growth restriction, congenital malformations secondary to oligohydramnios (retarded ossification of skull bones, limb positional deformities), fetal renal tubular pathology, neonatal renal failure, and early postnatal death. Most of these outcomes have been attributed to impaired fetal renal function that normally begins in the early second trimester of pregnancy. However, no systematic studies on the relationship between the adverse outcomes and enalapril gestational exposures are available. Thus, the causal role of enalapril in the adverse events reported in association with its use during gestation has not been examined.

The objectives of the present study are:

(1) To identify and characterize the profile of adverse pre- and postnatal manifestations reported to FDA in association with prenatal enalapril exposures, including information on timing and duration of treatment; and
(2) To examine the relationship between the reported adverse outcomes and prenatal enalapril exposure, taking timing and duration of exposure into account, as well as several other factors that could confound any observed association between exposure and outcome.

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Citation

Tabacova, S. A., Y. Tsong, R. Little, A. Vega, AND C Kimmel*. Adverse Pregnancy Outcomes Associated with Maternal Enalapril Antihypertensive Treatment. Pharmacoepidemiology and Drug Safety. Wiley InterScience, Silver Spring, MD, 12(8):633-646, (2003).

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