FDA will wait to change ACEI labels

June 12, 2006

Despite findings from a new study of ACE-inhibitor use during the first trimester of pregnancy, the FDA will not change the drugs' warning labels right now, the agency said in a recent conference call. The study, "Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors," published recently in the New England Journal of Medicine, found a 2.7 times higher risk for birth defects when the mother was taking an ACE inhibitor during the first trimester of pregnancy.

FDA will wait to change ACEI labels

Despite findings from a new study of ACE-inhibitor use during the first trimester of pregnancy, the FDA will not change the drugs' warning labels right now, the agency said in a recent conference call. The study, "Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors," published recently in the New England Journal of Medicine, found a 2.7 times higher risk for birth defects when the mother was taking an ACE inhibitor during the first trimester of pregnancy. Currently, the drugs' labels contain a black box warning alerting women to stop using the class of drugs as soon as possible if they become pregnant as use during the second and third trimesters of pregnancy has been associated with injury and even death to the fetus. The FDA considers the study results to be "preliminary data" and will need to review additional data before making a labeling change, but the agency said it would notify the public about the new findings.

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