Since bupropion (Zyban°) first came onto the market in 2001, numerous adverse effects have come to light: cutaneous and allergic reactions, convulsions, suicide attempts, myocardial infarctions, deaths.

Data also suggest an increased risk of cardiac malformations in children exposed to bupropion in utero. In 2004, data from one registry of 423 pregnancies drew attention to cardiac malformations following exposure to bupropion during pregnancy. In 2008 the data from this registry, which by then covered 806 pregnancies exposed to bupropion in the first trimester, also showed an increased frequency of cardiac malformations.  

In 2010 a study of more than 10 000 children showed a higher frequency of exposure to bupropion during pregnancy in children who had left-side cardiac abnormalities. 

Aside from pregnancy, bupropion already has a negative harm-benefit balance. The data suggesting a risk of cardiac malformations in newborns is one more reason to exclude bupropion from the treatments to be offered to pregnant women. When a drug treatment is judged desirable, nicotine is an acceptable choice.

Fetuses and newborns exposed to bupropion should in particular be monitored for heart problems.

©Prescrire 1 April 2012

"Bupropion: congenital heart defects (continued) " Prescrire Int 2012; 21 (126): 97. (Pdf, subscribers only).