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FDA Video: SSRI Antidepressant Birth Defects

Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of serious, life-threatening birth defects linked to SSRI antidepressants.

In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribing SSRIs and other antidepressant medications for pregnant women and those planning a pregnancy.

The first study followed pregnant women with a history of depression who had been taking antidepressants before they got pregnant. Those who stopped their medications were five times more likely to experience a relapse of depression during their pregnancy than those who continued to take the drugs. FDA’s Advisory recommends that women who are pregnant or considering pregnancy not discontinue their antidepressants without consulting their physician. If the medication is stopped, patients should be monitored closely for signs of a relapse.

The second study found that infants born to women who had taken SSRIs after the 20th week of pregnancy experienced a sixfold increase in the risk of persistent pulmonary hypertension of the newborn (PPHN). PPHN is a life-threatening condition that becomes evident soon after birth and occurs in one to two per thousand births in the U.S. Infants with PPHN become hypoxemic because of abnormal blood flow through the heart and lungs.

This link between SSRIs and PPHN has not been investigated in other studies, and FDA is seeking more information about the possible risk of PPHN in infants born to mothers who took antidepressants during pregnancy. In the meantime, FDA has asked the manufacturers of all SSRIs to add the potential risk of PPHN to their prescribing information.

The possible risk of PPHN adds to concerns raised in other reports that infants of mothers who take antidepressants late in pregnancy may experience problems such as irritability, difficulty in feeding, and in rare cases, difficulty in breathing. And the labeling for Paxil (paroxetine hydrochloride) now cautions that exposure during the first trimester could be associated with an increased risk of cardiac anomalies in the newborn.

These two studies underscore the need to weigh the risk of relapse in a pregnant woman who discontinues her antidepressant medication against the risk of rare but serious adverse effects in her infant if she continues to take the drug.

Other Birth Defects Linked to Antidepressants

In addition to the aforementioned conditions, antidepressant use has also been linked to the following 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
  • Pulmonary Stenosis
  • Craniosynostosis – cranial skull defect
  • Omphalocele – abdominal wall defect
  • Gastroschisis – abdominal wall defect
  • Esophageal Stenosis
  • Club Foot
  • Anal Atresia
  • Spina Bifida

Do I Have a SSRI Antidepressant Birth Defect Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in SSRI antidepressant lawsuits. We are handling individual litigation nationwide and currently accepting new SSRI birth defect cases in all 50 states.

If you or a loved one have taken and SSRI antidepressants while pregnant and given birth to a child with a congenital birth defect, you should contact us immediately. You may be entitled to compensation and we can help.

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