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ACE Inhibitors May Boost Birth Defects

Study Shows Risk May Start Earlier Than Expected

Birth Defects, ACE Inhibitors

Here are details on birth defects seen in babies born with first-trimester exposure to ACE inhibitors:

  • 7 babies had more than one malformation.
  • Cardiovascular malformations were the most common type of major birth defect, affecting 9 babies.
  • Malformations of the central nervous system were the second most common type of major birth defect, affecting 3 babies.
  • The babies' moms ranged in age from 17-41 years.
  • The babies were born at 32-41 weeks of gestational age.

"Many of these defects ... are potentially treatable. ... Some are much worse," the FDA's Robert Temple, MD, told reporters in the teleconference.

Temple is the associate director for medical policy at the FDA's Center for Drug Evaluation and Research.

He says Cooper's study doesn't show a "single pattern that at least is more typical" for birth defects in babies exposed to ACE inhibitors in the first trimester. There were very few cases of certain birth defects in Cooper's study, making it hard to draw conclusions, notes Temple.

Questions Remain

"One of the things that these data don't tell you is how early in pregnancypregnancy the drugs cause problems. We just don't know that," says Temple.

He says that for women who are pregnant or might become pregnant, "the main thing is to reconsider their medication."

Birth defects are "common" and can happen without exposure to ACE inhibitors, Kweder notes. She calls ACE inhibitors "very effective drugs" that are "generally well tolerated."

"We all believe that we want to see more data here but this is important enough and impressive enough to tell people about," Temple says.

Second Opinion

The New England Journal of Medicine also includes an editorial about Cooper's study. The editorial was written by J.M. Friedman, MD, PhD of Canada.

Friedman -- who wasn't involved in Cooper's study -- works in Vancouver, at the University of British Columbia's medical genetics department.

"Clearly, more research on the teratogenic potential of ACE inhibitors in early pregnancy is needed," Friedman writes. Teratogens are substances that can cause birth defects.

"This is not the last word on the subject, but it is shocking to realize that it is almost the first," Friedman adds, noting that many other drugs haven't been studied in pregnant women.

Drugs typically aren't tested on pregnant women.

Women's Options

Cooper's study doesn't make recommendations about other options for pregnant women needing treatment for high blood pressurehigh blood pressure.

"I think it's fair to say that not a lot is known about any of the options for women and their use in pregnancy," Kweder says. "There have not been very many studies on antihypertensives and pregnancy. There are a few minor exceptions but even those studies are not large."

"Trying to be able to provide better, more scientifically robust information about safety in medicines in pregnancy is an important priority for FDA," Kweder says.

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