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Ventricular Septal Defects Lawsuit

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

Paxil Linked to Ventricular Spetal Heart Defects

In 1992, the US Food and Drug Administration (FDA) approved the use of a new antidepressant created by GlaxoSmithKline called Paxil (generically known as paroxetine). The drug had been found to effectively treat many conditions, including depression, obsessive-compulsive disorder, and panic/anxiety disorders. The drug quickly became one of the most prescribed antidepressants in the world, with thousands of people in the United States and millions worldwide using the medication to treat various disorders.

Then, in September of 2005, the FDA issued a warning to healthcare professionals and the public announcing the results of recent studies that had found an alarming link between Paxil and birth defects in the children of mothers taking Paxil during pregnancy. The American Medical Association estimates that over 40,000 pregnant women in the United States take antidepressants regularly. The main problem is that many antidepressants, including Paxil, have been found to cross the placenta and therefore affect the child inside.

The studies found that taking Paxil during the first trimester of pregnancy doubled the risk of the baby being born with a congenital defect, frequently a defect in the heart. The most common defect noted was a ventricular septal defect which is a hole in the center wall of the heart between the left and right lower chambers of the heart (ventricles). This hole in heart defect allows deoxygenated blood from the right side of the heart to mix with the ultraoxygenated blood from the left side of the heart, depleting the effectiveness of the blood pumped throughout the body.

Babies born with a ventricular septal defect can show symptoms of congestive heart failure, such as shortness of breath, cyanosis (skin or fingertips turning blue), and fatigue. Many cases require open heart surgery to close the holes and ensure that the child’s blood is pumping properly. The signs of a serious heart defect appear within the first few weeks of life and, even with proper treatment, up to 20% of the children affected will not survive. The ones that do survive may have health problems for the rest of their lives.

As a result of these studies, GlaxoSmithKline has changed the warning label for Paxil to reflect the increased risk of birth defects. The FDA has changed Paxil’s drug category to Category D, indicating that the drug has been found to cause harm to human fetuses. 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. 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. Due to the fact that stopping Paxil altogether frequently causes severe withdrawal symptoms, healthcare professionals need to carefully weigh the risks and benefits before choosing a course of action. Thousands of lives depend on them making the correct choice.

Learn More About Ventricular Septal Defects: American Heart Association | Mayo Clinic | Cincinnati Children's Hospital | Children's Hospital Boston

Other Birth Defects Linked to Antidepressants

In addition to VSDs, a number of other extremely serious birth defects have been linked to antidepressant use including:

  • Atrial Septal Defects (ASD) - also known as ‘hole in the heart’ defects
  • 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
  • Omphalocele - abdominal wall defect
  • Gastroschisis - abdominal wall defect
  • Esophageal Stenosis
  • Club Foot
  • Anal Atresia
  • Spina Bifida