Women in their first trimester of pregnancy should avoid taking angiotensin-converting enzyme, or ACE, inhibitors, according to a report in the June 8 New England Journal of Medicine. Earlier studies have identified the danger of using ACE inhibitors during the second and third trimesters.
Research Report
ACE Inhibitors Pose Danger in First Trimester of Pregnancy
By News Staff
Infants exposed to ACE inhibitors during the first trimester only had a greater risk of major congenital malformations than infants who had no such exposure, say the authors of "Major Congenital Malformations After First-Trimester Exposure to ACE Inhibitors." There was no increased risk from fetal exposure to other antihypertensive medications during the first trimester. The malformations associated with ACE inhibitor use affected the cardiovascular and central nervous systems, according to the study.
The study used Tennessee Medicaid data, vital records, medical records and U.S. Census data. ACE inhibitors are prescribed to treat hypertension and to preserve kidney function in people with diabetes; however, because diabetes itself is strongly associated with malformations in infants, the authors restricted the study to children whose mothers had no evidence of diabetes before or during pregnancy.
The study population was 29,507 infants born between 1985 and 2000 to mothers who were enrolled in Medicaid throughout pregnancy. Of the infants in the study, 209 were exposed to ACE inhibitors only during the first trimester; 202 were exposed to other antihypertensive drugs; and 29,096 were not exposed to antihypertensive drugs during gestation.
"Fetal exposure to ACE inhibitors restricted to the first trimester of pregnancy, an exposure that was previously considered to be safe, was associated with a risk of a major congenital malformation that was 2.7 times as great as the risk with no fetal exposure to ACE inhibitors or other antihypertensive medications," say the authors. "Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided."
"These study findings raise a new and potentially important safety concern for a woman who is taking ACE inhibitors before she or her doctor knows that she is pregnant," said AHRQ Director Carolyn Clancy, M.D., in a June 7 press release. "Clinicians who treat women of childbearing age and pregnant women should be aware of these new findings and consider whether to use other treatment options to control hypertension or kidney damage from diabetes."
The FDA and Agency for Healthcare Research and Quality funded the study.
The researchers, led by William Cooper, M.D., M.P.H., of Vanderbilt Children's Hospital in Nashville, conducted the study at the AHRQ-sponsored Vanderbilt University Center for Education and Research on Therapeutics in Nashville.
The study used Tennessee Medicaid data, vital records, medical records and U.S. Census data. ACE inhibitors are prescribed to treat hypertension and to preserve kidney function in people with diabetes; however, because diabetes itself is strongly associated with malformations in infants, the authors restricted the study to children whose mothers had no evidence of diabetes before or during pregnancy.
The study population was 29,507 infants born between 1985 and 2000 to mothers who were enrolled in Medicaid throughout pregnancy. Of the infants in the study, 209 were exposed to ACE inhibitors only during the first trimester; 202 were exposed to other antihypertensive drugs; and 29,096 were not exposed to antihypertensive drugs during gestation.
"Fetal exposure to ACE inhibitors restricted to the first trimester of pregnancy, an exposure that was previously considered to be safe, was associated with a risk of a major congenital malformation that was 2.7 times as great as the risk with no fetal exposure to ACE inhibitors or other antihypertensive medications," say the authors. "Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided."
"These study findings raise a new and potentially important safety concern for a woman who is taking ACE inhibitors before she or her doctor knows that she is pregnant," said AHRQ Director Carolyn Clancy, M.D., in a June 7 press release. "Clinicians who treat women of childbearing age and pregnant women should be aware of these new findings and consider whether to use other treatment options to control hypertension or kidney damage from diabetes."
The FDA and Agency for Healthcare Research and Quality funded the study.
The researchers, led by William Cooper, M.D., M.P.H., of Vanderbilt Children's Hospital in Nashville, conducted the study at the AHRQ-sponsored Vanderbilt University Center for Education and Research on Therapeutics in Nashville.
