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Some blood pressure drugs previously thought to be safe when taken early in pregnancy now appear to substantially raise the risk of major birth defects, doctors say.
Babies whose mothers took ACE inhibitors in their first trimester were more than twice as likely to be born with serious heart and brain problems than those not exposed to any pressure-lowering medicines, a large study in Tennessee found. Other types of blood pressure drugs did not raise the risk to babies.
ACE inhibitors already carry a strong Food and Drug Administration "black box" warning about their dangers in the later stages of pregnancy, and the label says the drugs should be discontinued when pregnancy is detected. But little has been known about their early effects.
Based on the new findings, taking these drugs during early pregnancy "cannot be considered safe and should be avoided," lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday's New England Journal of Medicine.
The most common defects included holes in the heart and neurological and kidney problems.
Researchers found no increased risk among babies whose mothers took another type of blood pressure medication. But they said it is premature to declare those drugs safe to use during early pregnancy.
In the early 1990s, the FDA required pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. The label warned that ACE inhibitors can cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.
Babies whose mothers took ACE inhibitors in their first trimester were more than twice as likely to be born with serious heart and brain problems than those not exposed to any pressure-lowering medicines, a large study in Tennessee found. Other types of blood pressure drugs did not raise the risk to babies.
ACE inhibitors already carry a strong Food and Drug Administration "black box" warning about their dangers in the later stages of pregnancy, and the label says the drugs should be discontinued when pregnancy is detected. But little has been known about their early effects.
Based on the new findings, taking these drugs during early pregnancy "cannot be considered safe and should be avoided," lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday's New England Journal of Medicine.
The most common defects included holes in the heart and neurological and kidney problems.
Researchers found no increased risk among babies whose mothers took another type of blood pressure medication. But they said it is premature to declare those drugs safe to use during early pregnancy.
In the early 1990s, the FDA required pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. The label warned that ACE inhibitors can cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.
