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 FDA-approved labels recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. ACE inhibitor drugs are labeled pregnancy category C for the first trimester of pregnancy, and are labeled pregnancy category D during the second and third trimesters. It has already been established that ACE inhibitors used during the second half of pregnancy can cause a variety of birth defects and death. Healthcare professionals should take these findings into consideration with other information about a patient's medical situation when prescribing ACE inhibitors. At this time, based on this one observational study, the FDA does not plan to change the pregnancy categories for ACE inhibitors. FDA will work with the Agency for Healthcare Quality and Research to identify other potential sources of data that will help determine the degree of risk associated with first trimester exposures to these drugs.
Cooper WO et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med 2006 Jun 8; 354:2443-51.
