Paxil Birth Defect Litigation

In December 2005, the Food and Drug Administration (FDA) released a statement alerting health care professionals and patients about early results from new studies of Paxil, suggesting that Paxil increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times more likely to have a baby with a heart defect when compared to women taking other antidepressants or no antidepressant at all. The heart defects identified in the studies were atrial and ventricular septal defects, or holes in the walls of the chambers of the heart.

The FDA has asked the manufacturer of Paxil, GlaxoSmithKline, to change the pregnancy category from C to D, a stronger warning, after results of the two studies were released. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus.

The FDA has posted a Public Health Advisory addressing the potential increased risk of birth defects associated with a woman's use of Paxil during pregnancy. To access the FDA website go to http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm.

If you or a family member took Paxil during a pregnancy, or are currently taking Paxil and are pregnant, please contact us by email at pbclawfirm.com@pbclawfirm.com for further information.

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