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Congenital Heart Defects & Paxil Lawsuit

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Paxil has been linked in recent studies to the development of congenital heart defects in infants born to mothers who were administered Paxil during pregnancy. The most common forms of heart defects linked to the drug include atrial septal defects or ventricular septal defects (holes in the walls of the chambers of the heart).

Results of two early studies reviewed by the FDA showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect compared with women who took other antidepressants or women in the general population

Watch the FDA Video: SSRI Antidepressants Linked to Birth Defects

Atrial Septal Defects (ASD)

As described by the Mayo Clinic, an atrial septal defect (ASD) is a hole in the wall between the two upper chambers of the heart. The condition is present from birth (congenital). Smaller atrial septal defects may close on their own during infancy or early childhood. The health effects of holes that remain open often don’t show up until adulthood — usually by age 40. Many people don’t realize they have an atrial septal defect until then. Sometimes a doctor detects an atrial septal defect during a newborn exam, or during a routine exam later in life.

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

Ventricular Septal Defects

As described by the Mayo Clinic, if your baby has a ventricular septal defect (VSD) — an abnormal opening between the heart’s lower pumping chambers — you’re bound to be concerned. Fortunately, a ventricular septal defect, also called a “hole in the heart,” is a common heart defect that’s present at birth (congenital). The defect is readily treatable. Smaller ventricular septal defects often close on their own or don’t cause problems. Others need surgical repair. Many kids with ventricular septal defects have normal, productive lives with few related problems.

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

FDA Statement | Paxil & Congenital Birth Defects

Download: FDA Warning Advising of Risk of Birth Defects with Paxil (pdf)

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. Women taking Paxil should not stop taking it without first talking with their physician.

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

Other Birth Defects Linked to Antidepressants

In addition to congenital heart defects, Paxil and other antidepressants have been linked to the following birth defects:

  • Valve Problems – malformed or stuck and won’t close
  • Atrial Septal Defects (ASD)
  • Ventricular Septal Defects (VSD)
  • 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

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