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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Study: women taking Wellbutrin risk having babies with heart defect

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It goes by the names of Wellbutrin®, Wellbutrin XL®, and Wellbutrin XR® – drugs frequently taken for depression. Also trading under the name Zyban is a stop-smoking aid.

Generically called Bupropion, a recent study showed a risk of having babies born with a heart birth defect. These are very serious side effects.

When will the FDA take action to alert patients and doctors about the study showing the link of Wellbutrin to heart defects? When will the FDA require GlaxoSmithKline to add a black box warning for the potential problem.

Perhaps this lack of action from the FDA will change with the new study from the American Journal of Obstetrics & Gynecology.

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    The risk, according to the study is relatively low (2 in 1000 pregnancies) for usage of the drug during the first trimester of the pregnancy. But that is more than double the risk you would expect in the absence of the drug being used. So it is an alarming increase in the rate of these defects and is cause for concern and further study to determine if the bupropion is the cause of the defects.

    And for me, the real question is whether there are safer alternatives, considering that the severity of the impact on these children. At the very least, it is a decision that women should be able to make in consultation with their doctors – and that requires information being provided to the doctor by the drug manufacturer. Thus, as with most drug side effects, the key is to get the information to the doctor so that they are aware of the risk and can help the patient make an informed decision.

    I want to make clear that these results are early indicators of a possible problem and are not yet conclusive. But further study is needed and the medical community needs to be made aware.