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FDA Public Health Advisory
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)]
A new study in the New England Journal of Medicine
suggests that angiotensin-converting enzyme inhibitor drugs (ACE
inhibitors or ACEIs) may be associated with increased risk of birth
defects when used in the first three months of pregnancy. While the
results of this single study do not establish a causal relationship
between exposure to the drugs early in pregnancy and birth defects,
they are concerning. ACE inhibitors are already known to have risks
to the developing infant when used in the last six months of
pregnancy. The prescribing information for all ACE inhibitor drugs
has long emphasized that women who become pregnant should be taken
off ACE inhibitors as soon as possible to avoid exposure of the
fetus in the second and third trimesters, which is known to cause
fetal abnormalities, especially related to the kidneys and related
structures. The findings from this new study, which was supported by
funding from the Agency for Healthcare Policy & Research and FDA,
confirm the importance of this recommendation.
ACE inhibitor drugs are used to treat high blood pressure by slowing
the body’s production of a hormone that constricts blood vessels.
The labels for all the ACE inhibitors begin with a boxed warning
that the drugs may harm unborn babies in the second and third
trimester of pregnancy. FDA recommends the following:
- Healthcare providers who care for women of reproductive age
should counsel those who are treated with an ACE inhibitor about
the potential risks of these drugs throughout pregnancy,
especially during the second and third trimesters.
- Pregnant women should only be prescribed ACE inhibitors if the
expected benefit clearly exceeds the potential risk.
- Women who become pregnant should have their ACE inhibitor
changed to a different medication as soon as possible.
- Women who are taking ACE inhibitors to treat high blood
pressure should tell their healthcare professionals if they are
planning a pregnancy or think they might be pregnant.
The observational study published on June 8, 2006 (one that
reports on patients who are being treated with usual medical care,
not in a clinical trial) reports that babies whose mothers had taken
an ACE inhibitor during the first three months of pregnancy had an
increased risk of birth defects, compared with babies whose mothers
had not taken any drugs for high blood pressure.
ACE inhibitors are labeled with a pregnancy category D for the last
six months (the second and third trimesters) and C for the first
three months. Pregnancy category D means that there have been
studies in pregnant women showing that the drug was associated with
some risk for the unborn baby (fetus), but the benefit of the drug
may still outweigh that risk for some patients. Pregnancy category C
means that the risk in pregnancy is possible but unknown, because no
good studies of pregnant women have been done, and animal studies
either have shown risk in pregnancy or have not been done. For more
information about the pregnancy categories and also about the risk
of leaving diseases untreated in pregnant women, see the story
posted at
http://www.fda.gov/fdac/features/2001/301_preg.html#danger
At this time, based on this one observational study, the FDA does
not plan to change the pregnancy categories for ACE inhibitors. FDA
will work with the Agency for Healthcare Quality and Research to
identify other potential sources of data that will help determine
the degree of risk associated with first trimester exposures to
these drugs.
For the recent study, see William O. Cooper, Sonia Hernandez-Diaz,
Patrick G. Arbogast, Judith A. Dudley, Shannon Dyer, Patricia S.
Gideon, Kathi Hall, and Wayne A. Ray. "Major congenital
malformations after first-trimester exposure to ACE inhibitors."
New England Journal of Medicine, volume 354 number 23, pages
2443-2451. June 8, 2006.
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Date created: June 7, 2006 |
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