ACE inhibitors may raise birth defect risk

By Staff
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NEW YORK, June 8 (Reuters) When pregnant women take ACE inhibitor medication during their first trimester, the risk of the infants having major malformations is more than doubled, according to a study in this week's New England Journal of Medicine.

Angiotensin-converting-enzyme (or ACE) inhibitors are widely used to treat high blood pressure, and are often prescribed for people with diabetes. Many formulations are available, sold under numerous brand names.

''Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided,'' Dr William O Cooper, from Vanderbilt University School of Medicine in Nashville, and colleagues caution.

It has already been recognized that taking ACE inhibitors during the second and third trimesters can lead to birth defects, the investigators note. It was believed that use of the drugs during the first three months of pregnancy was safe, and this idea was reinforced by studies in animals, the authors note.

However, Cooper's group was not convinced. To look into the issue, they used data from Tennessee Medicaid records to identify 29,507 infants born between 1985 and 2000, excluding infants born to mothers with diabetes. In the first trimester, 209 infants were exposed to ACE inhibitors and 202 were exposed to other blood pressure drugs.

Information regarding major malformations was obtained from linked records and hospitalization claims during the first year of life.

All told, malformations were diagnosed in 856 infants (2.9 per cent). Eighteen were in the ACE inhibitor group, four in the other antihypertensive medication group, and 834 among the remaining infants.

After adjusting for demographics, year of birth, neighborhood income, and presence of chronic illnesses, Cooper and his associates estimated that the risk of major congenital malformations was 2.71-times higher in the ACE inhibitor group than the group that had no exposure to blood pressure medications.

In contrast, there was no sign of increased risk among infants exposed to other types of blood pressure medication.

''Clearly more research on the (malformation) potential of ACE inhibitors in early pregnancy is needed,'' Dr J M Friedman says in a related editorial. This study ''is not the last word on the subject, but it is shocking to realize that it is almost the first.'' Moreover, the increased risk ''appears to be great enough to require discussion with all women of reproductive age who are prescribed ACE inhibitors,'' adds Friedman, from the University of British Columbia, in Vancouver.

If a woman who is using an ACE inhibitor discovers she is pregnant, she should be switched to another antihypertensive drug ''immediately,'' he recommends, and should have a fetal sonogram at about 18 weeks of gestation.

REUTERS PR HS1032

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