[DRUGALERT] Birth Defects and ACE Inhibitors

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Public Citizen's Worst Pills, Best

Pills News Online Drug E-Alert

FDA PUBLIC HEALTH ADVISORY: BIRTH DEFECTS WITH HIGH BLOOD

PRESSURE-LOWERING DRUGS CONTAINING ANGIOTENSIN-CONVERTING ENZYME (ACE)

INHIBITORS

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 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.

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.

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)

A full report on the New England Journal of Medicine study will appear

in the August 2006 issue of Worst Pills, Best Pills News.

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.

--

ne Holden, MS, RD < fivestar@... >

" Ask the Parkinson Dietitian " http://www.parkinson.org/

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