Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors

Cooper, William O.; Hernández–Dı́az, Sonia; Arbogast, Patrick G.; Dudley, Judith A.; Dyer, Shannon; Gideon, Patricia; Hall, Kathi; Ray, Wayne A.

doi:10.1056/nejmoa055202

Cited by 1,053 publications

(398 citation statements)

References 31 publications

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“…14). Although first-trimester effects of ACE inhibitors were suggested by one study, the majority of data supports a fetotoxic hazard only beyond the first trimester (30)(31)(32).…”

Section: Discussionmentioning

confidence: 94%

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Padberg

Wacker

Meister

et al. 2014

Antimicrob Agents Chemother

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bFluoroquinolones are avoided during pregnancy due to developmental toxicity in animals. The aim of this study was to assess the fetal risk after intrauterine fluoroquinolone exposure. We performed an observational study of a prospectively ascertained cohort of pregnant women exposed to a fluoroquinolone during the first trimester. Pregnancy outcomes were compared to those of a cohort exposed to neither fluoroquinolones nor teratogenic or fetotoxic drugs. The outcomes evaluated were major birth defects (structural abnormalities of medical, surgical, or cosmetic relevance), spontaneous abortion, and elective termination of pregnancy. Pregnancy outcomes of 949 women with fluoroquinolone treatment were compared with those of 3,796 nonexposed controls. Neither the rate of major birth defects (2.4%; adjusted odds ratio [OR adj ], 0.91; 95% confidence interval [CI], 0.6 to 1.5) nor the risk of spontaneous abortion (adjusted hazard ratio [HR adj ], 1.01; 95% CI, 0.8 to 1.3) was increased. However, there was a nonsignificant increase in major birth defects after exposure to moxifloxacin (6/93, 6.5%; crude odds ratio [OR crude ], 2.40; 95% CI, 0.8 to 5.6). Neither a critical exposure time window within the first trimester nor a specific pattern of birth defects was demonstrated for any of the fluoroquinolones. The rate of electively terminated pregnancies was increased among the fluoroquinolone-exposed women (HR adj , 1.32; 95% CI, 1.03 to 1.7). The gestational ages at delivery and birth weights did not differ between groups. Our study did not detect an increased risk of spontaneous abortion or major birth defects. These reassuring findings support the recommendation to allow fluoroquinolone use in early pregnancy in selected cases. After the use of moxifloxacin, a detailed fetal ultrasound examination should be considered.

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“…14). Although first-trimester effects of ACE inhibitors were suggested by one study, the majority of data supports a fetotoxic hazard only beyond the first trimester (30)(31)(32).…”

Section: Discussionmentioning

confidence: 94%

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Padberg

Wacker

Meister

et al. 2014

Antimicrob Agents Chemother

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“…Cooper et al 104 reported an additional risk of malformation among infants exposed to ACE inhibitors during the first trimester. Ideally, women taking an ACE inhibitor or angiotensin receptor blocker who desire to become pregnant should be advised to stop taking these drugs before conception to minimize the risk of fetal abnormality.…”

Section: Medications In Pregnancymentioning

confidence: 99%

Management of Pregnancy in Patients With Complex Congenital Heart Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association

Canobbio¹,

Warnes²,

Aboulhosn³

et al. 2017

Circulation

320

303

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Today, most female children born with congenital heart disease will reach childbearing age. For many women with complex congenital heart disease, carrying a pregnancy carries a moderate to high risk for both the mother and her fetus. Many such women, however, do not have access to adult congenital heart disease tertiary centers with experienced reproductive programs. Therefore, it is important that all practitioners who will be managing these women have current information not only on preconception counseling and diagnostic evaluation to determine maternal and fetal risk but also on how to manage them once they are pregnant and when to refer them to a regional center with expertise in pregnancy management.

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“…[37] Angiotensin-converting enzyme (ACE) inhibitors are teratogenic and can cause renal dysgenesis, oligohydramnios, calvarial and pulmonary hypoplasia, intrauterine growth restriction, and neonatal renal failure, leading to death of the fetus as early as the first trimester. [38,39] Similar anomalies have been reported with angiotensin II receptor blockers (ARBs). [40] ACE inhibitors and ARBs should be discontinued prior to conception, with appropriate birth control measures while on these agents.…”

Section: Drugs and The Kidneymentioning

confidence: 64%

Pregnancy and the kidneys

Wearne

2014

S Afr Med J

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Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors

Abstract: Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided.

Cited by 1,053 publications

References 31 publications

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Management of Pregnancy in Patients With Complex Congenital Heart Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association

Pregnancy and the kidneys

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