June 9, 2006

ACE inhibitors may pose more birth defect risks

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William Cooper, M.D., M.P.H.

ACE inhibitors may pose more birth defect risks

The Food and Drug Administration is looking at evidence examined by researchers at the Monroe Carell Jr. Children's Hospital at Vanderbilt to determine if new warnings need to be put on common blood pressure medications regarding an increased risk of birth defects for babies whose mothers take the medications during the first trimester of pregnancy.

William Cooper, M.D., M.P.H., associate professor of Pediatrics, was first author of a study in the New England Journal of Medicine, along with colleagues from the departments of Pediatrics, Preventive Medicine and Biostatistics. Cooper and co-authors found that infants born to mothers who took angiotensin converting enzyme inhibitors (ACE inhibitors) during the first trimester of pregnancy had an increased risk of major birth defects compared with infants whose mothers did not take these medications.

“We knew ACE inhibitors were a possible cause of adverse fetal outcomes when exposure occurred later in pregnancy, but it has not been well studied in the first trimester,” Cooper said.

“We were very surprised that even after controlling for other risk factors, the TennCare records we examined showed a clear increase in a broad range of birth defects following first trimester-only exposures.”

This research is important because the number of women of childbearing age who develop high blood pressure and are prescribed ACE inhibitors is increasing in this country, according to other data included in the study.

ACE inhibitors already carry a warning stating that they can cause injury and even death to the developing fetus when used during the second and third trimesters of pregnancy.

The warning states that use of ACE inhibitors should be discontinued as soon as possible when pregnancy is detected.

Cooper and his co-authors performed the research within the Child and Adolescent Health Research Unit at Children's Hospital.

The study was jointly funded by the FDA and Vanderbilt's Center for Education and Research on Therapeutics, which is funded through the Department of Health and Human Services' Agency for Healthcare Research and Quality. Results were published in the June 8 issue of the New England Journal of Medicine.