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Wellbutrin Birth Defects: Wellbutrin Use During First Trimester Linked to Cardiac Birth Defects

Wellbutrin is a prescription medication that has been proposed to treat health conditions ranging from depression and Seasonal Affective Disorder to weight loss and smoking cessation in the twenty-five years since it was developed by GlaxoSmithKline.  Primary prescribed as an anti-depressant, Wellbutrin (bupropion hydrochloride) is classified as a aminoketone.  The most recent version of the drug, Wellbutrin XL, has an extended release feature.  Bupropion was first developed in the mid-1960s, and then approved for use in 1985.  Soon after the drug first received FDA approval, bupropion was recalled after it was found to cause seizures.  Lower doses mitigated that risk, but health problems, including birth defects, have been traced to Wellbutrin use.

Wellbutrin Birth Defects Revealed in CDC Study

Findings on Wellbutrin birth defects were published in the CDC's Birth Defects Prevention Study.  The study found that fetal exposure to Wellbutrin increase the risk for a cardiac birth defect.  The most common heart birth defect that is linked to Wellbutrin is Left Outflow Cardiac Birth Defect.

Public was Unaware of Wellbutrin Birth Defects Risks

Prior to the availability of data linking Wellbutrin to birth defects, Wellbutrin was commonly prescribed to women during their first trimester.  Women who had struggled with depression prior to pregnancy, or who were trying to quit smoking because they were pregnant, were prime candidates for Wellbutrin.  A lack of scientific data regarding the risks of taking Wellbutrin during pregnancy led many people to speculate that Wellbutrin was safe when in fact, it was not.

Bupropion Pregnancy Registry Documents Wellbutrin Birth Defects Rates

After the Wellbutrin had been on the market for over ten years, GlaxoSmithKline finally began to track results related to Wellbutrin (and other Bupropion drugs such as Zyban) use during pregnancy.  The Burpropion Pregnancy Registry  documented voluntary cases over the next decade.  In March of 2008, GlaxoSmithKline analyzed the data, finding that 3.6% of infants who had fetal exposure to Wellbutrin during the first trimester were born with birth defects.  (Only 675 people participated, so this study does not present conclusive evidence.)  Wellbutrin cardiac birth defects took place in 1.3% of the pregnancies that were tracked in the study.  Only birth defects that were detected at the time of birth were reported in most cases.

Wellbutrin Birth Defects and the National Birth Defects Prevention Study

The National Birth Defects Prevention Study (NBDPS) is a longterm case-control examination of environmental and genetic risk factors for more than 30 types of major birth defects.  The study is funded by the Centers for Disease Control and Prevention (CDC). The NBDPS evaluated the linkage between Wellbutrin and Zyban (bupropion) use and cardiac birth defects on children born between October 1, 1997 and roughly December 31, 2004. The study looked at a total of 12,383 case infants, 6,853 of which were diagnosed with at least 1 of the 4 major categories of heart birth defects and 5,763 with 1 of the 6 categories of non-cardiac birth defects that were studied. An additional 5,869 control infants were analyzed.

Wellbutrin Left Outflow Heart Birth Defects

The National Birth Defects Prevention Study concluded that Wellbutrin and Zyban use during the period starting one month prior to conception until three months after conception is linked to an increase in cardiac birth defects. Left Outflow Cardiac Birth Defect is the most common wellbutrin birth defect.

More information can be found at The Onder Law Firm's Wellbutrin birth defects website at