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.

The research raises troubling questions about the lack of safety data for many drugs prescribed to pregnant women.

According to 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 FDA said more research is needed before it considers changing the warning label to specifically include the risks during the first trimester.

The sale of ACE inhibitors results in billions of dollars for each company involved in their production and marketing. How long do you think it will take the FDA to respond actively to this danger?



  1. Terry says:

    The news story failed to mention what I feel is a very important fact: what was the actual risk *with* the ACE inhibitors versus *without*.

    From http://www.ahrq.gov/news/press/pr2006/acepr.htm:
    “Among infants exposed to ACE inhibitors in the first trimester, the proportion born with major congenital malformations was 7.1 percent, compared with 1.7 percent among infants exposed to other antihypertensive medications. The rate of major congenital malformations in the general population is about 3 percent—or 3 infants out of every 100 pregnancies.”

    Those are some pretty significant numbers, especially in that *other* antihypertensives cut the risk almost in half.

  2. Todd says:

    High blood pressure and pregnancy don’t mix well to begin with.

    Besides the stress of dealing with the kids as they grow up(!), high blood pressure can be potentially disasterous for both mother and child in some pregnancies. If the mother is taking medications for it to begin with, the mother had best be in close consultations with her doctors…


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