Wellbutrin SR tablet 150mg (Bupropion Safety update – possible increased risk of some congenital cardiovascular malformations)

GlaxoSmithKline would like to inform healthcare professionals of the possible increased risk of congenital cardiovascular malformations associated with bupropion. Results from an epidemiology study investigating the risk of congenital cardiovascular malformations following bupropion exposure during the first trimester of pregnancy as well as findings from other studies suggest a potential increased risk of some congenital cardiovascular malformations such as ventricular septal and left outflow tract heart defects. The pregnancy and pre-clinical safety data sections of the product inserts for all bupropion containing products would be updated accordingly to warn of this potential increase in risk. Healthcare professionals are encouraged to consider this new information and to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant.