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Zyban, generically known as bupropion hydrochloride, is manufactured by GlaxoSmithKline and was originally approved in a stronger form, Wellbutrin, by the FDA in 1985 as an antidepressant. Wellbutrin has also been associated with serious or even fatal birth defects.
In May 1997, Zyban, a lower dose of bupropion was approved for use as a smoking cessation aid and helps to reduce the side effects associated with nicotine withdrawal.
The drug, however, carries a Pregnancy Category C classification, meaning that animal reproduction studies have shown an adverse effect on fetuses but that no adequate or well-controlled studies in humans have been performed.
In 2010, the American Journal of Obstetrics & Gynecology released a study that found that children of mothers who “used bupropion during early pregnancy had more than double the risk of heart defects known as left outflow tract defects, compared with infants whose mothers had not used the drug,” according to Reuters.
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 during pregnancy. A teratogen is a drug or other substance capable of interfering with the development of a fetus that can ultimately result in serious birth defects.
If you, a family member or friend took Zyban during early pregnancy and had a baby born with a birth defect, contact Zyban lawyer Kimberly Barone Baden by email or by calling 1.800.768.4026 to learn more about your legal rights.
Lawyers at Motley Rice are currently reviewing potential Zyban lawsuits. Our birth defect attorneys have worked with many woman who allege their children suffered birth defects as a result of medical drugs such as Effexor, Zoloft, Wellbutrin and Zofran.