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The FDA has taken several steps to emphasize to physicians and patients that angiotensin-converting enzyme (ACE) inhibitors can cause injury and even death to the developing fetus in the second and third trimester. While labeling for ACE inhibitors was changed several years ago to state that women who take the drug in the second and third trimester of pregnancy are running the risk of causing significant harm to fetuses, including kidney failure and face or skull deformities, additional cases of fetal injury and death continue to be reported. As a consequence, the agency has required manufacturers to send a "Dear Doctor" letter with the important warning information. The agency has also required a number of changes in the products' approved labeling, including the addition of a boxed warning entitled "Use In Pregnancy," and the expansion of the "Information for Patients" subsection. Pharmacists have been alerted to the labeling changes by
Warnings on Use of ACE Inhibitors in Second and Third Trimester of Pregnancy. JAMA. 1992;267(18):2445. doi:10.1001/jama.1992.03480180031008