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Wellbutrin, generically known as bupropion hydrochloride, is an antidepressant drug prescribed to treat major depressive disorder and seasonal affective disorder. First approved by the FDA in 1985, bupropion was available for several years only under the brand name Wellbutrin. In 1996, the FDA approved a sustained-release tablet of this drug called Wellbutrin SR and, in 2003, approved an extended-release tablet known as Wellbutrin XL. In 1997, a lower-dose form of bupropion, Zyban, was approved for use as a smoking cessation drug. Both Wellbutrin and Zyban have been associated with an increased risk of congenital heart defects if taken during pregnancy.
Wellbutrin carries a Pregnancy Category C classification, meaning that animal reproduction studies have shown an adverse effect on the fetus but that no adequate or well-controlled studies in humans have been performed.
A 2010 case-control study published in the American Journal of Obstetrics and Gynecology suggests that women who take Wellbutrin during early pregnancy may run a greater risk for having a baby born with a heart birth defect. This study identifies a positive association between early pregnancy Wellbutrin use and left outflow tract heart birth defects.
Congenital heart defects affect approximately 40,000 babies each year, and one of the primary known causes of such birth defects is the ingestion of teratogenic drugs, or drugs that are capable of interfering with fetus development, during pregnancy.
Lawyers at Motley Rice are reviewing potential Wellbutrin lawsuits and represent clients whose children have been allegedly harmed by Wellbutrin. If you, a family member or friend took Wellbutrin during early pregnancy and had a baby born with a birth defect, contact Wellbutrin lawyer Kimberly Barone Baden by email or by calling 1.800.768.4026 to learn more about your legal rights.