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Ricky Bagolie
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FDA PUBLIC HEALTH ADVISORY: BIRTH DEFECTS WITH HIGH BLOOD PRESSURE-LOWERING DRUGS CONTAINING ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS

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The Food and Drug Administration (FDA) issued a Public Health Advisory on June 8, 2006 concerning the possibility of birth defects in children whose mothers were taking the widely prescribed family of high blood pressure lowering drugs known as angiotensin converting enzyme (ACE) inhibitors in their first trimesters (the first three months of pregnancy).

The FDA Public Health Advisory was based on research just published in the June 8th issue of the New England Journal of Medicine that found that infants who had been exposed to ACE inhibitors during the first trimester had an 2.71-fold increase in major birth defects. This risk could have been as high as 4.27- or as low as 1.72-fold compared to infants who had no exposure to blood pressure-lowering drugs in the first trimester.

The full text of the Public Health Advisory is available on the FDA’s Web site at http://www.fda.gov/cder/drug/advisory/ACEI.htm.
Half of the birth defects were various types of heart defects and half included some malformations of the central nervous system, the urinary system, or other systems. The mothers taking an ACE inhibitor were on average older and more likely to have other chronic conditions than were the mothers not taking any blood pressure lowering drugs

The possibility of birth defects when ACE inhibitors are used in the second and third trimesters is well known, but this is the first study to raise concerns about their safety in the first trimester. All marketed ACE inhibitors carry the following black box warning in their professional product labels or package inserts:

FDA BLACK BOX PREGNANCY WARNING

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.

The list below names a number of ACE inhibitor products, including combination drugs. The brand names are in parentheses:

DRUGS CONTAINING ONLY AN ACE INHIBITOR
Benazepril (LOTENSIN)
captopril (CAPOTEN)
enalapril (VASOTEC)
fosinopril (MONOPRIL)
lisinopril (PRINIVIL, ZESTRIL)
moexipril (UNIVASC)
perindopril (ACEON)
quinapril (ACCUPRIL)
ramipril (ALTACE)
trandolapril (MAVIK)

DRUGS CONTAINING AN ACE INHIBITOR AND A THIAZIDE DIURETIC
benazepril and hydrochlorothiazide (LOTENSIN HCT)
captopril and hydrochlorothiazide (CAPOZIDE)
enalapril and hydrochlorothiazide (VASERETIC)
lisinopril and hydrochlorothiazide (PRINZIDE, ZESTORETIC)

DRUGS CONTAINING AN ACE INHIBITOR AND A CALCIUM CHANNEL BLOCKER
amlodipine and benazepril (LOTREL)
diltiazem and enalapril (TECZEM)
felodipine and enalapril (LEXXEL)
verapamil and trandolapril (TARKA)

What You Can Do

You should contact your physician immediately if you are pregnant and are taking an ACE inhibitor at any stage in pregnancy.

The drug of choice for pregnant patients with mild-to-moderate high blood pressure before they became pregnant is methyldopa (ALDOMET). Because blood pressure typically drops during the first trimester, some women with mild hypertension may be able to manage without any medication during that time.

DO NOT discontinue a high blood pressure lowering drug without first consulting the prescriber