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Abdominal Birth Defects, Omphalocele & Paxil Lawsuit


In a recent study, Paxil was linked to the development serious congenital side effect called omphalocele. The results of the National Birth Defects Prevention Study of Infants showed that babies born to mothers who took Paxil may have an increased risk of developing omphalocele than babies born to mothers who did not take Paxil during pregnancy.


Watch the FDA Video: SSRI Antidepressants Linked to Birth Defects

What is Omphalocele?

An omphalocele is a congenital (present at birth) abdominal wall birth defect in which the infant’s intestine or other abdominal organs stick out of the belly button (navel). In babies with an omphalocele, the intestines are covered only by a thin layer of tissue and can be easily seen.

Results from the study prompted GlaxoSmithKline (GSK) to send a letter to doctors and healthcare professionals advising them of a change to the Pregnancy subsection of the PRECAUTIONS section in the labels for PAXIL regarding the increased risk of omphalocele.

Learn More About Omphalocele: U.S. Gov MedlinePLUS | Children’s Hospital BostonCleveland Clinic | Health Guide

Other Birth Defects Linked to Antidepressants

In addition to omphalocele, Paxil and other antidepressants have been linked to the following life-threatening birth defects:

  • Atrial Septal Defects (ASD) – also known as ‘hole in the heart’ defects
  • Ventral Septal Defects (VSD) – hole in the heart wall
  • Valve Problems – malformed or stuck and won’t close
  • Tricuspid Valve (Ebstein’s Anomaly)
  • Mitral Valve
  • Transposition of the Great Arteries / Vessels
  • Tetralogy of the Fallot
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Hypoplastic Right Heart Syndrome (HRHS)
  • Tricuspid Atresia
  • Aortic Stenosis
  • Pulmonary Atresia
  • Patent Ductus Arteriosus (PDA)
  • Coarctation of the Aorta
  • Truncus Arteriosus
  • Tricuspid Valve Stenosis
  • Heart Murmur
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Pulmonary Stenosis
  • Craniosynostosis – cranial skull defect
  • Gastroschisis – abdominal wall defect
  • Esophageal Stenosis
  • Club Foot
  • Anal Atresia
  • Spina Bifida

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