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High Blood Pressure and Pregnancy - Birth Defects increase if Mother takes ACE Inhibitors during Pregnancy

June 9th, 2006

High Blood Pressure and Pregnancy - Birth Defects increase if Mother takes ACE Inhibitors during Pregnancy


A study funded by HHS’ Agency for Healthcare Research and Quality and the Food and Drug Administration found that if a mother takes angiotensin converting enzyme (ACE) inhibitors during the first trimester of pregnancy there was an increased risk of major congenital malformations when compared to mothers that did not take these medications.  The study was first published in the June 8th issue of the New England Journal of Medicine.

ACE inhibitors are used to either lower blood pressure or protect the kidney in diabetics.  The FDA has a “black box” warning that says that it can cause injury and even death to a developing fetus when used during the second and third trimesters of pregnancy.  The ACE inhibitor should be discontinued as soon as possible when a woman becomes aware that she is pregnant.


“These study findings raise a new and potentially important safety concern for a woman who is taking ACE inhibitors before she or her doctor knows that she is pregnant,” said AHRQ Director Carolyn M. Clancy, M.D. “Clinicians who treat women of childbearing age and pregnant women should be aware of these new findings and consider whether to use other treatment options to control hypertension or kidney damage from diabetes.”

The study was conducted at Vanderbilt University Center for Education and Research on Therapeutics (CERTs) located in Nashville.  The lead researcher was William William O. Cooper, M.D., M.P.H., of Vanderbilt Children’s Hospital.

The study included data that was gathered from the Tennessee Medicaid program for 29,507 infants born between 1985 and 2000.  There were 209 infants that were recognized as being exposed to ACE inhibitors during the first trimester of the pregnancy.  Another 202 infants were exposed to other antihypertensive medications.  The remaining 29,096 did not have any exposure to these blood pressure lowering drugs during pregnancy.


The amount of major congenital malformations in the general population is around 3 percent or 3 out of every 100 pregnancies.  The infants in this study that were exposed to ACE inhibitors in the first trimester had a 7.1 percent incidence of a major congenital malformation.  The infants that were exposed to the other antihypertensive medication were at 1.7 percent having birth defects.

When the researchers compared the 29,096 infants that had no antihypertensive medication at all against the infants that had exposure to the ACE inhibitor during the first trimester those exposed to the ACE inhibitors had a 2.71 times higher chance for being born with a major congenital malformation.  The ACE inhibitors increased the risk of the infant having cardiovascular and central nervous system defects.  The researchers said that the ACE inhibitor caused defects include a hole in the heart or artrial septal defects, open blood vessels that flow into the baby’s lung, hydrocephalus, and spina bifida.  They did not see an increase risk for other types of malformations which include musculoskeletal, gastrointestinal, and genital systems.


“This study raises the important issue of a woman and her physician being aware of potential risks of medications that she might be taking before she becomes pregnant,” Dr. Cooper said. “While we believe the increased risk that we found in our study represents a true increase, further studies are needed to confirm these findings and to assess the risks of specific drugs and durations of exposure.”

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Nicole Wilson
Best Syndication

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