FDA warns women of Paxil birth defect dangers

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The FDA released an Alert in July 2006 about the increased risk of deadly birth defects in babies whose mothers were using Paxil.

The alert reads as follows:

FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension

A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.

If you or someone you know has used Paxil and had a baby with birth defects, it may be in your best interest to consult an attorney to discuss your rights. For a free consultation, simply click on the form to the right of this page.