Following the recognition that thalidomide, when used by pregnant women, induced a characteristic pattern of severe congenital anomalies in many of the offspring, pharmaceutical manufacturers, regulatory agencies and a variety of public health entities have faced the challenge and responsibility of assessing the safety of medication with respect to the developing fetus (Lenz, 1961; McBride, 1961). This is a daunting task for a variety of reasons, not the least of which is the number and variety of medications to which a pregnant woman is likely to be exposed. Although pharmacovigilance for a variety of adverse reproductive outcomes, ranging from spontaneous abortion to long-term postnatal functional deficits or learning disabilities, is appropriate in assessing pharmaceutical safety during pregnancy, the focus of this chapter will be limited to major congenital anomalies. As congenital anomalies are the leading cause of infant mortality in the United States, prevention of even the small proportion that are likely to be attributable to maternal medication use is a worthy goal of any pharmacovigilance effort (Rosenberg et al., 1996).

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