Following the recognition in the 1960s that thalidomide, when used by pregnant women, induced a characteristic pattern of severe congenital anomalies in many of the offspring, pharmaceutical manufacturers, regulatory agencies.
Drug Safety in
Pregnancy
Following
the recognition in the 1960s 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 respon-sibility 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 spectrum of
adverse reproductive outcomes, ranging from spontaneous abortion to long-term
postnatal func-tional 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 and number of years of potential life lost in
the United States, the 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; Yang, Khoury and Mannino, 1997).
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