Drugs
Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs and Pregnancy
[ACE inhibitor drugs include Benazepril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)]
FDA ALERT [06/2006]: On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated (see below for more information about the study). According to the approved labels, ACE inhibitor drugs are labeled as pregnancy category C for the first trimester of pregnancy, though they are labeled pregnancy category D during the second and third trimesters and the existing prescribing information recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. Because of the preliminary nature of the newly published data, the FDA does not plan to change the pregnancy categories at this time, but healthcare professionals should take these findings into consideration with other information about a patient’s medical situation during early pregnancy.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.
Related Information
Labeling and Regulatory History from Drugs@FDA
Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs
- Regulatory History of Lotensin and Labeling Information
Benazepril (marketed as Lotensin) - Regulatory History of Capoten
Captopril (marketed as Capoten) - Regulatory History of Vasotec and Labeling Information
Enalapril/Enalaprilat (marketed as Vasotec oral and injectable) - Regulatory History of Monopril and Labeling Information
Fosinopril (marketed as Monopril) - Regulatory History of Zestril and Labeling Information
Lisinopril (marketed as Zestril) - Regulatory History of Prinivil and Labeling Information
Lisinopril (marketed as Prinivil) - Regulatory History of Univasc
Moexipril (marketed as Univasc) - Regulatory History of Aceon and Labeling Information
Perindopril (marketed as Aceon) - Regulatory History of Accupril
Quinapril (marketed as Accupril) - Regulatory History of Altace
Ramipril (marketed as Altace) - Regulatory History of Mavik
Trandolapril (marketed as Mavik)
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