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Caution on use of ACE inhibitors in First Trimester

Discussion in 'Diabetes in Pregnancy' started by Ellen, Aug 2, 2006.

  1. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
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    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=54#3

    Caution on use of ACE inhibitors in First Trimester

    A recent study in the New England Journal of Medicine suggests that ACE inhibitors, which are widely used to treat hypertension, may be associated with an increased risk of major congenital malformations when used by women during the first trimester of pregnancy.

    The labeling for ACE inhibitors already states that these drugs can produce major congenital malformations, but that precaution is aimed at preventing harm to the fetus during the second and third trimesters of pregnancy. This new study focuses on the first trimester, a time when neither the woman nor her doctor may realize that she's pregnant.

    This one study does not establish a causal relationship between ACE inhibitors and birth defects, but it does raise some reason for concern. So FDA is recommending is that ACE inhibitors be prescribed for pregnant women only if the expected benefit clearly exceeds the potential risk. If a woman becomes pregnant while she is on an ACE inhibitor, the recommendation is to change to a different drug as soon as possible.

    Women who are taking these drugs, or a combination product containing ACE inhibitors, to tell their practitioner if they're planning a pregnancy or think they might be pregnant. And they should be counseled about the potential risks throughout pregnancy, especially during the second and third trimesters.

    ACE inhibitor drugs include: Lotensin (benazepril), Capoten (captopril), Vasotec oral and injectable (enalapril/enalaprilat), Monopril (fosinopril), Zestril (lisinopril), Prinivil (lisinopril), Univasc (moexipril), Aceon (perindopril), Accupril (quinapril), Altace (ramipril), Mavik (trandolapril)

    ACE inhibitors combined with other antihypertensive drugs include: Capozide (captopril/hydrochlorothiazide), Lotrel (benazepril, amlodipine), Vaseretic (enalopril/hydrochlorothiazide), Prinzide (lisinopril/ hydrochlorothiazide), Accuretic (Accupril/ hydrochlorothiazide)

    Additional Information:
    FDA MedWatch Safety Alert 2006 - Angiotensin-converting enzyme inhibitors (ACE inhibitors) drug class – June 7, 2006
    http://www.fda.gov/medwatch/safety/2006/safety06.htm#Angiotensin
     

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