ABSTRACT
Regulatory agencies and a variety of public health entities face the responsibility of evaluating the safety of maternal use of medications with respect to the developing fetus. This is a challenging task for a variety of methodological reasons, but is also a monumental undertaking because of the large number of medications to which pregnant women are likely to be exposed and for whom this information is critically needed. As congenital anomalies are the leading cause of infant mortality and number of years of potential life lost in the United States, well-designed and well-conducted human studies that can identify potentially teratogenic medications are needed to help prevent teratogen-induced malformations. Of similar importance, well-designed human studies are also needed to provide reassurance regarding the absence of substantial increased risks for birth defects so that clinicians and patients can appropriately and confidently use necessary medications during pregnancy (1,2).
