Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors) Associated with Birth Defects in First Trimester
June 9, 2006
Angiotensin-converting enzyme inhibitors (ACE inhibitors) may increase the risk of major congenital malformations in infants whose mothers take the drug in the first trimester of pregnancy. A recent New England Journal of Medicine article found that infants exposed to ACE inhibitors during the first three months of pregnancy exhibited more birth defects than unexposed infants. ACE inhibitor labeling already includes a boxed warning describing the increased fetal risk for exposures during the second and third trimesters of pregnancy.
Prescribing information for the ACE inhibitors currently recommends discontinuation of therapy as soon as possible after becoming pregnant. Pregnancy category ratings will not change at this time. ACE inhibitors include benazepril (Lotensin), captopril (Capoten), enalapril/enalaprilat (Vasotec oral and injectable), fosinopril (Monopril), lisinopril (Zestril; Prinivil), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik). Refer patients to their primary care provider for evaluation and follow-up when discontinuing ACE inhibitor therapy.
More information can be obtained online at the following web sites:
- MedWatch Alert (June 8, 2006):
- ACE Inhibitor FDA Drug Information Page:
- New England Journal of Medicine Article (access restricted to subscribers or University of Utah Campus):
June 9, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.