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First-trimester ACE inhibitors linked to fetal malformation: FDA has issued a public health advisory.(Obstetrics)
The use of ACE inhibitors in the first trimester has been linked to an array of congenital malformations of the fetal cardiovascular system, CNS, and renal system, and therefore can no longer be considered safe, according to an observational study involving more than 29,000 pregnancies conducted by Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his associates.
In light of these data, the Food and Drug Administration has issued a public health advisory to educate clinicians and consumers about these study findings and to remind them to consider other treatment options for hypertension in pregnancy, agency officials said at a press teleconference.
However, the agency considers the study findings "preliminary" and will not change the black box warning, or the designation of ACE inhibitors as pregnancy category D drugs, "until we've examined the findings and sought additional evaluation from other information sources," said Dr. Sandra L. Kweder, deputy director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research.
ACE inhibitors have been contraindicated in the second and third trimesters for at least a decade because they were known to be associated with conditions including oligohydramnios, intrauterine growth retardation, hypocalvaria, renal dysplasia, anuria, renal failure, and fetal death.
The drugs' effects were thought to result directly from impairment of fetal renal function, which doesn't develop until later in pregnancy.
Their use in the first trimester has never been linked to adverse outcomes, but until now it has been assessed only in animal studies and "small, uncontrolled series and unpublished reports," according to Dr. Cooper and his associates.
The researchers used a large Medicaid database to assess birth outcomes in 29,507 infants born in Tennessee between 1985 and 2000. They identified 209 infants who were exposed to ACE inhibitors in the first trimester, and 202 who were exposed to other antihypertensive drugs in the first trimester.
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