FDA ALERT [06/2006]: On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated (see below for more information about the study). According to the approved labels, ACE inhibitor drugs are labeled as pregnancy category C for the first trimester of pregnancy, though they are labeled pregnancy category D during the second and third trimesters and the existing prescribing information recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. Because of the preliminary nature of the newly published data, the FDA does not plan to change the pregnancy categories at this time, but healthcare professionals should take these findings into consideration with other information about a patient’s medical situation during early pregnancy.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.