Warning strengthened on Paxil birth defect risks

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Warning strengthened on Paxil birth defect risks

The Food and  Drug Administration has strengthened its warning regarding the antidepressant paroxetine (Paxil).

What happened: Based on the results of two studies, the Food and Drug Administration (FDA) has strengthened its warning on the antidepressant paroxetine (Paxil). FDA stated in a Dec. 8, 2005, public health advisory that Paxil increases the risk of birth defects in women taking the drug during their first trimester of pregnancy. Women who take Paxil during their first three months of pregnancy are nearly two times more likely to give birth to a child with a birth defect — in particular a heart defect — than are women taking other antidepressants, the FDA stated.

What does this mean to you? If you're taking Paxil and you're in your first trimester or are considering getting pregnant, see your doctor about switching to another antidepressant or discontinuing treatment. Don't stop taking Paxil without contacting your doctor first, as side effects may occur after immediate cessation of the drug. Your doctor may recommend a phased withdrawal from the medication or may determine that for you the benefits of Paxil outweigh the risk.

Last Updated: 12/09/2005
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