Anti-Depressant Birth Defect Studies, Warnings & Litigation

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 16, 2021

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There have been numerous studies linking anti-depressant SSRI drugs and birth defects that have led to FDA warnings – and a lot of litigation. Pregnant women who were prescribed SSRI drugs such as Celexa, Lexapro and Effexor and whose child suffered a birth defect may be entitled to compensation. According to birth defect lawyers, manufacturers have not provided adequate warnings – even though medical studies show the dangerous relationship between birth defects and pregnant women who took anti-depressants.

Anti-Depressant Birth Defect Studies

Numerous studies have linked anti-depressant SSRI drugs taken by pregnant woman with birth defects such as autism; cardiac defects such as heart valve abnormalities, septal defects and coarctation of the aorta; limb, facial or genital malformation; neural-tube defects of the brain, spinal cord or spina bifida or PPHN (Persistent Pulmonary Hypertension of the Newborn). Some of those studies include:

  • Archives of General Psychiatry; 2011. Mothers who took an SSRI while pregnant were twice as likely to give birth to a child with an autism spectrum disorder (ASD).
  • Canadian Medical Association Journal, 2010. Women who take SSRIs during pregnancy have more than double the risk of miscarrying.
  • Pediatrics Journal, 2010. Children born to women who took SSRIs while pregnant have a greater risk of developmental milestone delays in early childhood.

Other studies which highlight anti-depressant use and an increased risk of birth defects include:

  • Alliance for Human Research Protection; 2006. Harvard / Stanford – “Psychiatry’s Opinion Leaders Financial Ties to Industry.”
  • Neural Psychiatry Reviews; 2006. “Risks Associated with Antidepressant Use During Pregnancy.”
  • New England Journal of Medicine; 2006. “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn.”
  • Alliance for Human Research Protection; 2006. “Safety of Newborn infants Threatened by Rx Antidepressants During Pregnancy.”

Anti-Depressant Birth Defect Warnings

The U.S. Food & Drug Administration (FDA) has issued two warnings about SSRI birth defects – one in 2005 and another in 2006. In 2005, the Administration warned that infants born to women who had first trimester SSRI exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). In 2006, the FDA warned that pregnant women exposed to SSRIs late in their third trimester (after their 20th week) reported developing PPHN (Persistent Pulmonary Hypertension of the Newborn) – which consists of breathing and lung problems.

Anti-Depressant Birth Defect Litigation

Although SSRI birth defect lawyers say that the FDA’s warnings should be more stringent, they also say that manufacturers shoulder the ultimate liability and should provide better warnings to consumers about the dangerous side effects of SSRIs – especially to pregnant women. It’s this failure to warn amid warnings from published studies that has led to litigation against manufacturers – including Wyeth-Ayerst Laboratories, which manufactures Effexor and Forest Laboratories that manufactures both Celexa and Lexapro.

Birth defect litigation is expected to not only continue, but drastically increase according to SSRI birth defect lawyers who point to a $2.5 million Paxil verdict against GlaxoSmithKline. The jury in that case found that the company’s failure to warn a pregnant mother about the possible risks of Paxil birth defects was directly responsible for her son being born with a heart condition.

Mothers who were prescribed an anti-depressant such as Effexor, Lexapro or Celexa while pregnant and whose child suffered birth defects should consult with an SSRI birth defect attorney to determine whether that drug may have been responsible for your child’s injuries. Compensation in these cases can be substantial – especially for children who will have to endure a lifetime of treatment, receive special care or may be forever limited in their earnings potential.

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