June 7, 2006—A study published by The New England Journal of Medicine concluded that women who use ACE inhibitors during the first trimester of pregnancy are at a greater risk of giving birth to a child with serious birth defects. Drugs belonging to the ACE inhibitor class previously had been linked to birth defects in the second and third trimesters, and carry a black box warning for those risks.

Following news of the study, the FDA recommended that women using ACE inhibitors reconsider use of the drug before or during pregnancy. The FDA does not have any present plans to revise warnings for drugs in this class. The agency previously has been criticized for its slow response to the Vioxx crisis.

The study analyzed data on 29,507 babies born between 1985 and 2000. Of the 29,507 births, 411 babies were exposed to blood pressure drugs during the first trimester alone. About half of those babies were exposed to ACE inhibitors, with the other half exposed to blood pressure drugs outside that class.

The results of the study are alarming. Of the 29,507 babies born during the subject time period, 856 (3%) were born with birth defects. When isolating only those babies exposed to ACE inhibitors, 18 (7%) had birth defects.

We found that fetal exposure to ACE inhibitors restricted to the first trimester of pregnancy, an exposure that was previously considered to be safe, was associated with a risk of a major congenital malformation that was 2.7 times as great as the risk with no fetal exposure to ACE inhibitors or other antihypertensive medications.

The New England Journal of Medicine reported the following birth defects among the babies examined as part of the study:

• 7 babies had more than one malformation
• 9 babies had cardiovascular malformations
• 3 babies had malformations of the central nervous system

If an ACE inhibitor led to birth defects in your child, he or she may be entitled to compensation. You should act immediately to contact a lawyer experienced in matters involving dangerous pharmaceuticals to protect your child's rights.

O'Steen & Harrison, PLC presently is investigating legal claims on behalf of those injured by ACE inhibitors. We invite you to contact us for a free, confidential consultation about your legal rights.

We will represent children and their families throughout the United States. We can help you, too, wherever you live.

For free answers to your questions about ACE inhibitors and birth defects, please call us toll-free at 1-800-883-8888 or complete this online contact form.

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