The Food and Drug Administration has warned that children born to women who take Paxil (paroxetine) while they are pregnant face an increased risk of developing congenital heart defects or other birth defects. The FDA’s Paxil warnings came in 2005 and 2006 after multiple studies found that taking the antidepressant during pregnancy could increase the risk of birth defects by up to six times.
In 2005, the FDA reported that taking Paxil during the first trimester of pregnancy could double the risk to a child of developing birth defects. According to two studies cited in the FDA warning, the most common birth defects identified by researchers were atrial septal defects (ASD) and ventral septal defects (VSD), or holes in the walls of the heart.
A 2006 study published in the New England Journal of Medicine found that children born to women who take antidepressants such as Paxil late in their pregnancy are six time more likely to develop persistent pulmonary hypertension of the newborn (PPHN), a serious and potentially fatal circulatory condition.
Paxil has also been associated with a number of other serious congenital heart defects and birth defects, including hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), craniosynostosis, patent ductus arteriosus, bicuspid aortic valve, tricuspid stenosis, cardiomyopathy, omphalocele, spina bifida, anencephaly, cleft mitral valve, club foot and limb reductions.
In July 2010, GlaxoSmithKline, the manufacturer of Paxil, agreed to pay $1 billion to settle more than 800 Paxil lawsuits filed on behalf of children who developed birth defects after their mothers used Paxil during pregnancy.
If you or a loved one gave birth to a child with ASD, VSD, PPHN or other congenital heart or birth defects after taking Paxil while pregnant, contact the attorneys at Hissey Kientz, LLP to receive a free consultation about your legal rights. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form to the right of this page.