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A new study has found that a popular class of blood pressure drugs known as ACE inhibitors nearly triples the risk of birth defects if taken during the first trimester.
ACE inhibitors have long been linked with birth defects, but previous studies had limited the risk to the second and third trimesters only – the time during which developing fetal kidneys are associated with certain known birth defects.
Since fetal kidneys don''t begin to function until three months after conception, researchers had discounted the possibility that the drugs could cause birth defects during that time.
“Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided,” concluded the study, which was published in this week''s New England Journal of Medicine.
Researchers at Vanderbilt University School of Medicine in Tennessee examined the hospital records of nearly 30,000 births to women covered by Medicaid between 1985 and 2000.
Women who took an ACE inhibitor during the first trimester were three times more likely to deliver a baby with a congenital malformation than those who did not. The defects the study found included heart, limb, face, brain, and spinal cord.
The Food and Drug Administration, which helped to fund the study, said it would issue a public health advisory on the new risks and consider broadening the “black box” warning ACE inhibitors are required to carry to include first trimester risks.
ACE inhibitors are a commonly prescribed class of drugs with nearly 150 million prescriptions dispensed last year alone. They have been on the market for 25 years and include Merck''s Vasotec, Pfizer''s Accupril, Bristol-Myers Squibb''s Capoten.
The drugs help to lower blood pressure in individuals with hypertension. Controlling blood pressure in pregnant women is especially important because of the potential health risks of high blood pressure to both the mother and fetus.
High blood pressure can cause kidney damage and toxemia – a life-threatening condition – in the mother and low birth weight in the baby.
“It certainly would make sense for pregnant women and their doctors to look for alternative medications,” said William O. Cooper, associate professor of pediatrics and lead author of the study.