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Paxil Birth Defects

The Food and Drug Administration has advised expectant mothers and those who plan to become pregnant to avoid taking the antidepressant Paxil during pregnancy. The agency’s warning came following studies that showed that Paxil doubles the risk of birth defects in children whose mothers who use the drug while they are pregnant.

The most common form of birth defects cited in the FDA’s Paxil warning were atrial septal defects (ASD) and ventral septal defects (VSD), or holes in the walls of the chambers of the heart. Women who took Paxil during the first trimester of pregnancy were twice as likely to give birth to children with this form of congenital heart defect. In some cases, the symptoms caused by this type of birth defect were so severe that they required surgery.

Researchers have also found that using antidepressants such as Paxil during the late stages of pregnancy can increase the risk of another type of birth defect know as persistent pulmonary hypertension of the newborn (PPHN). This condition affects the way a newborn’s circulatory system develops after birth, usually leading to severe respiratory failure and hospitalization. A study published in the New England Journal of Medicine found that children who were exposed to antidepressants like Paxil in the womb are more than six times as likely to develop PPHN as those who were not.

Other birth defects that may be linked to Paxil include cardiomyopathy, craniosynostosis, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), omphalocele, patent ductus arteriosus, bicuspid aortic valve, tricuspid  stenosis, club foot, limb reductions, spina bifida, anencephaly, and cleft mitral valve.

As a result of these findings, the FDA has asked GlaxoSmithKline (GSK), the manufacturer of Paxil, to strengthen the drug’s pregnancy category from C to D. Category D drugs are those that research has demonstrated can cause danger to the fetus. The company also added new information concerning research into the side effects of Paxil.

Hundreds of families have filed Paxil lawsuits against GSK, alleging that the company concealed information for decades about the risk of Paxil side effects. Despite these allegations and a growing body of evidence highlighting the risk of birth defects, neither the FDA or GSK have chosen to issue a Paxil recall.

If you used Paxil, Zoloft or other antidepressants during pregnancy and gave birth to a child with heart defects or other congenital birth defects, contact the lawyers at Hissey Kientz, LLP to find out more about your rights. You can reach us by calling toll-free at 1-888-776-5552, or by filling out the free case evaluation form to the right of this page.

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