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Atrial Septal Defects Lawsuit

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Collen Clark Published by Collen Clark

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

Paxil Linked to Atrial Spetal Heart Defects

According to the American Medical Association, more than 40,000 pregnant women in the United States regularly take antidepressants. One of the most popular and commonly prescribed antidepressants is the drug Paxil (known generically as paroxetine). Released in 1992 by GlaxoSmithKline, it quickly became the most prescribed antidepressant on the market due to the drug’s success in treating everything from anxiety disorders to depression to phobias.

In 2005, the manufacturer of the popular antidepressant changed the warning label on the drug to inform patients and the medical community about a new problem linked to the use of Paxil. These newly discovered side effects affected the babies born to mother’s using Paxil during pregnancy. Recent studies had found that taking Paxil during the first trimester of pregnancy led to a doubled risk of the babies being born with a congenital defect. Exposure to Paxil is now considered extremely dangerous in the first trimester as that is when fetal heart development occurs.

The most common congenital heart defect noted were hole in heart defects, such as an atrial septal defect. An atrial septal defect is a hole in the central wall of the heart which separates the left and right chambers of the upper area of the heart called the atrium. This hole allows the oxygen-rich blood of the left side of the heart to mix with the oxygen-depleted blood of the right side. Babies born with this defect can have a bluish tinge to their skin or under their fingernails, if a large amount of their blood is mixing.

During the development of the fetus, these holes in the heart are normal and allow the blood to bypass the lungs which develop later in the pregnancy. Within a few hours of birth these openings usually close to seal off the chambers of the heart. If these holes remain open, the oxygen-rich blood that is intended for the body is circulated back into the lungs. Babies born with an atrial septal defect can develop symptoms of congestive heart failure, including fatigue and shortness of breath, because the blood is over-circulating in the lungs.

The studies conducted indicated that the use of Paxil during the first trimester of pregnancy inhibited the maturation of the heart and the holes that normally closed within the first few hours of life outside the womb remained open. The signs and symptoms of serious heart defects were noted within the first few weeks of life, often resulting in the need for a surgical procedure to close the atrial septal defect. At the request of the US Food and Drug Administration (FDA), the manufacturer has recategorized Paxil as a Category D drug, meaning that it has been found to cause harm to human fetuses.

Paxil is used by millions of people worldwide, with sales reaching $1 billion annually. Commonly prescribed to treat conditions such as depression and anxiety disorders, medical professionals are currently taking a hard look at the risks and benefits of prescribing Paxil to their patients. Many organizations are recommending that women who are pregnant or may become pregnant to avoid taking Paxil due to the potential risk of their baby being born with a congenital defect. Experts estimate that there are hundreds of infants born with Paxil-related birth defects and, even with the proper treatment, 20% of the babies do not survive.

Learn More About Atrial Septal Defects: American Heart Association [1] | Mayo Clinic [2] | Cincinnati Children's Hospital [3] | Children's Hospital Boston [4]

Birth Defects Linked to Antidepressants

In addition to atrial septal defects, antidepressants have also been associated with the following life-threatening birth defects:

  • Ventricular Septal Defects (VSD)
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Tricuspid Valve (Ebstein’s Anomaly)
  • Mitral Valve Prolapse
  • Transposition of the Great Arteries (TGA)
  • Transposition of the Great Vessels (TGV)
  • Tetralogy of Fallot (TOF)
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Hypoplastic Right Heart Syndrome (HRHS)
  • Tricuspid Atresia
  • Aortic Stenosis
  • Pulmonary Atresia (PA)
  • Patent Ductus Arteriosus (PDA)
  • Coarctation of the Aorta
  • Truncus Arteriosus
  • Tricuspid Valve Stenosis
  • Heart Murmur
  • Pulmonary Stenosis
  • Gastroschisis - abdominal wall defect
  • Esophageal Stenosis
  • Clubfoot
  • Anal Atresia
  • Spina Bifida