Angiotensin-converting enzyme (ACE) inhibitors can cause fetal harm when administered to a pregnant woman. Women should stop taking an ACE inhibitor as soon as possible after pregnancy is detected. ACE inhibitors reduce fetal renal function and increase fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. 1-14
The American College of Obstetricians and Gynecologists strongly recommends that women of reproductive age with chronic hypertension not use ACE inhibitors, angiotensin receptor blockers (ARBs), renin inhibitors, or mineralocorticoid receptor antagonists, unless there is a compelling reason to do so, such as proteinuric renal disease.15
The 2017 American College of Cardiology and American Heart Association (ACC/AHA) hypertension guidelines state that hypertensive women who become pregnant should not be treated with ACE inhibitors, ARBs, or direct renin inhibitors (Class of Recommendation [COR] III: Harm, Level of Evidence [LOE] C-Limited Data [LD])*.12 The guideline also recommends that women who are planning to become pregnant or become pregnant should be switched from antihypertensives they are currently taking to either methyldopa, nifedipine, or labetalol during pregnancy (COR I, LOE C-LD).
*See ACC/AHA Class of Recommendation and Level of Evidence definitions below:
|
Class (Strength) of Recommendation
|
|
Class I (Strong)
|
Benefit >>>> Risk
|
|
Suggested phrases for writing recommendations:
· Is recommended
· Is indicated/useful/effective/beneficial
· Should be performed/administered/other
· Comparative-Effectiveness Phrases:
· Treatment/strategy A is recommended/indicated in preference to treatment B
· Treatment A should be chosen over treatment B
|
|
Class IIa (Moderate)
|
Benefit >> Risk
|
|
Suggested phrases for writing recommendations:
· Is reasonable
· Can be useful/effective/beneficial
· Comparative-Effectiveness Phrases:
· Treatment/strategy A is probably recommended/indicated in preference to treatment B
· It is reasonable to choose treatment A over treatment B
|
|
Class IIb (Weak)
|
Benefit ≥ Risk
|
|
Suggested phrases for writing recommendations:
· May/might be reasonable
· May/might be considered
· Usefulness/effectiveness is unknown/unclear/uncertain or not well established
|
|
Class III: No Benefit (Moderate)
(Generally LOE A or B use only)
|
Benefit = Risk
|
|
Suggested phrases for writing recommendations:
· Is not recommended
· Is not indicated/useful/effective/beneficial
· Should not be performed/administered/other
|
|
Class III: Harm (Strong)
|
Risk > Benefit
|
|
Suggested phrases for writing recommendations:
· Potentially harmful
· Causes harm
· Associated with excess morbidity/mortality
· Should not be performed/administered/other
|
|
Level (Quality) of Evidence
|
|
Level A
|
|
|
· High-quality evidence from more than 1 randomized control trial (RCT)
· Meta-analyses of high quality RCTs
· One or more RCTs corroborated by high-quality registry studies
|
|
Level B-R
|
(Randomized)
|
|
· Moderate-quality evidence from 1 or more RCTs
· Meta-analyses of moderate-quality RCTs
|
|
Level B-NR
|
(Nonrandomized)
|
|
· Moderate-quality evidence from 1 or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies
· Meta-analyses of such studies
|
|
Level C-LD
|
(Limited Data)
|
|
· Randomized or nonrandomized observational or registry studies with limitations of design or execution
· Meta-analyses of such studies
· Physiological or mechanistic studies on human subjects
|
|
Level C-EO
|
(Expert Opinion)
|
|
· Consensus of expert opinion based on clinical experience
|
References
- Lotensin [package insert]. Parsippany, NJ: Validus Pharmaceuticals LLC; 2019.
- Capoten [package insert]. Chestnut Ridge, NY: Par Pharmaceutical; 2017.
- Epaned [package insert]. Wilmington, MA: Azurity Pharmaceuticals, Inc.; 2020.
- Vasotec [package insert]. Bridgewater, NJ: Bausch Health US LLC; 2018.
- Enalaprilat [package insert]. Lake Forest, IL: Hospira, Inc.; 2021.
- Monopril [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2003.
- Qbrelis [package insert]. Wilmington, MA: Azurity Pharmaceuticals, Inc.; 2020.
- Prinivil [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; 2021.
- Zestril [package insert]. Morristown, NJ: Almatica Pharma LLC; 2020.
- Univasc [package insert]. Smyrna, GA: USB, Inc; 2012.
- Aceon [package insert]. Cincinnati, OH: Patheon Pharmaceuticals, Inc.; 2017.
- Accupril [package insert]. New York, NY: Parke Davis, Pfizer; 2021.
- Altace [package insert]. New York, NY: Pfizer Laboratories; 2022.
- Mavik [package insert]. Whippany, NJ: Halo Pharmaceutical Inc.; 2017.
- Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol 2013; 122 (5): 1122-1131.
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Hypertension 2017.
 inhibitor while pregnant.png)
.png)