Bupropion and Cardiac Birth Defects

Bupropion is a unique drug that is used both to treat depression and as an aid in smoking cessation. Because depression is not uncommon among women of childbearing age, and because women are encouraged to stop smoking during pregnancy, it was anticipated that some exposure among pregnant women would occur. Previous research has suggested that there may be an increased risk of certain heart defects called left outflow tract defects among infants born to women who have used bupropion in pregnancy. These defects include hypoplastic left heart syndrome and coarctation of the aorta.

Using data already collected as part of the Birth Defects Study (BDS) / Pregnancy Health Interview Study (PHIS), a large ongoing multicenter case-control surveillance program of birth defects, this investigation looked into the association between bupropion and these specific heart defects. The BDS/PHIS identifies infants with a wide range of malformations, as well as non-malformed infants, at referral and birth hospitals. Within 6 months of delivery, study nurses interview mothers about demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking and alcohol consumption; and dietary intake.

This study helped gather information to guide clinicians and women of child-bearing age in making decisions regarding treatment for depression in pregnancy.

Investigators and Study Staff

Allen A. Mitchell, M.D., Principal Investigator
Carol Louik, Sc.D., Co-Investigator
Stephen Kerr, Research Data Analyst

Study Details

Source of Funding:

GlaxoSmithKline, Inc.

Study Period:

September 2011 to May 2012