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.
Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs
- Benazepril (marketed as Lotensin)
- Captopril (marketed as Capoten)
- Enalapril/Enalaprilat (marketed as Vasotec oral and injectable)
- Fosinopril (marketed as Monopril)
- Lisinopril (marketed as Zestril and Prinivil)
- Regulatory History of Zestril and Prinivil and Labeling Information from Drugs@FDA
- Moexipril (marketed as Univasc)
- Perindopril (marketed as Aceon)
- Quinapril (marketed as Accupril)
- Ramipril (marketed as Altace)
- Trandolapril (marketed as Mavik)
Report Adverse Events to
MedWatch
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Date created: June 7, 2006 |