Bupropion is a unique drug that is used both to treat depression and as an aid in smoking
cessation. In 2008, the final report from the Bupropion pregnancy registry described 24
congenital malformations among the 675 women exposed to bupropion in the first trimester of
pregnancy. Of these, 9 had congenital heart disease of varying severity, including a number
of infants with ventricular septal defects (VSDs); of note, 2 of these 9 had coarctation of
the aorta. More recently, Alwan et al, in an analysis of data from the Centers for Disease
Control and Prevention's case-control National Birth Defects Prevention Study, reported an
increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that
includes coarctation of the aorta and hypoplastic left heart syndrome.
Data from the Slone Epidemiology Center Birth Defects Study will be used to test these
observations. The outcomes of primary interest will include those hypothesized to be
associated with bupropion in recent studies: left outflow tract defects considered as a
group. Coarctation of the aorta and hypoplastic left heart syndrome will also be examined
separately. All infants with congenital heart defects are further classified into subgroups
that are embryologically meaningful, including left outflow tract defects. In secondary
analyses, other heart defect classes for which there are adequate numbers of cases will be
evaluated.