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Omphalocele Lawsuit

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Paxil has been linked in recent studies to the development of Omphalocele in infants born to mothers who were administered Paxil during pregnancy.

Watch the FDA Video: SSRI Antidepressants Linked to Birth Defects

Paxil Linked to Abdominal Defects – Omphalocele

Over the last few years, several studies have focused on the safety of taking selective serotonin reuptake inhibitors (SSRI’s) such as the popular antidepressant, Paxil, during pregnancy with startling findings. These medications work by allowing the serotonin levels in the brain to increase, improving mood, appetite, memory, and sleep patterns. SSRI’s are frequently prescribed to treat everything from depression to panic disorders, with Paxil being the most prevalent and most prescribed SSRI in the world.

Thousands of people in the United States and millions of people worldwide take Paxil (generically known as paroxetine) regularly, including up to 40,000 pregnant women, according to the American Medical Association. Unfortunately, Paxil, as well as many other SSRI’s, have been found to cross the placenta and affect the fetus while still in the womb. This leads to an increased risk of the baby being born with a congenital defect. Studies have found that if Paxil is taken during the first three months of pregnancy, the risk of the child being born with a congenital defect is 2 to 6 times more likely.

One congenital defect linked to Paxil that worries the healthcare community is the increased risk of the baby being born with Omphalocele. Omphalocele is an abdominal defect in which the liver and/or intestines protrude from the abdomen into the umbilical cord or naval area at birth. Until about the tenth week of pregnancy, this protrusion is considered normal, after which the organs regress into the abdominal cavity of the fetus.

Omphalocele can be mild, with only a small amount of the intestines protruding, or severe, with most of the abdominal organs located outside of the body. Severe omphalocele needs to be treated with surgery, made much more difficult by the small size of the newborn’s abdomen. In some cases, the infant’s abdomen is abnormally small, because there was no need for the abdomen to expand and grow to accommodate the growing organs inside of it.

Due to the indications of the studies, GlaxoSmithKline has changed the warning label for Paxil to reflect the increased risk of birth defects, including omphalocele. The FDA has upgraded Paxil’s drug category to Category D, indicating that the drug has been found to cause harm to human fetuses. Many organizations are now warning women against taking Paxil if they are pregnant or planning to become pregnant. The FDA advises that healthcare professionals refrain from prescribing Paxil to women in their first three months of pregnancy due to these side effects, unless no other treatment option is viable.

Experts estimate that hundreds of babies have been born with Paxil-related birth defects due to the fact that many mothers and healthcare professionals had no idea about the effects on Paxil to unborn children. The fact that SSRI medications such as Paxil can be extremely difficult to stop due to the severe withdrawal symptoms also adds to the difficulty women face if they become pregnant while taking the drug. It is important that every consumer and healthcare professional be aware of the side effects and the risks to be able to choose a proper treatment and course of action. Thousands of lives depend on making the correct choice.

Learn More About Omphalocele: U.S. Gov MedlinePLUS | Children’s Hospital Boston | NYTimes.com Health Guide

Other Birth Defects Linked to Antidepressants

In addition to omphalocele, a large number of other birth defects have been linked to the use of antidepressants including:

  • 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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