The FDA reviewed two studies which found that women who took Paxil in the first three months of pregnancy were 1-1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall.

Recent studies suggest an increased risk of Paxil birth defects for pregnant women during their first trimester. According to the results of two studies, women who were taking Paxil® during the first three months of pregnancy were one and a half to two times more likely to have a baby with heart malformations than women on other antidepressants or women in the general population. Another study showed a link between Paxil and PPHN (persistent pulmonary hypertension)—a rare but life-threatening birth defect that can lead to multiple organ failure and death.

Heart Defects

In December 2005, the Food and Drug Administration alerted consumers to the increased risks of Paxil birth defects when taken during the first three months of pregnancy. Results of the studies showed the heart defects were, in most cases, atrial and ventricular septal defects, which are characterized by holes in the walls of the chambers of the heart. Heart-related Paxil® birth defects range in severity from minor, which may resolve without treatment, to severe conditions, which usually require surgical repair.


Several months after the initial FDA alert on the risk of Paxil birth defects, the New England Journal of Medicine published a study linking the popular antidepressant to PPHN. According to that study, women who used Paxil after week 20 of pregnancy were six times more likely to give birth to a baby with PPHN than women who used no antidepressants during pregnancy.

PPHN requires prompt diagnosis and treatment, and even still, the condition may prove fatal. Babies who survive the initial trauma of PPHN frequently suffer permanent damage—hearing and speech damage as well as damage to the brain, which can result in developmental delays and neurological deficits.

Paxil Birth Defects & Complications

Other possible Paxil birth defects and complications include:

  • Difficulties with breathing
  • Seizures
  • Vomiting
  • Low blood sugar
  • Tremor
  • Irritability

Due to the risk of Paxil birth defects, the FDA asked the drug’s maker to change the pregnancy category on the drug from C to D. The D category means that studies done in pregnant women have shown risks to the fetus.

If your baby was born with a Paxil® birth defect, please contact us to speak with a qualified attorney who can help protect and maximize your interests.

Paxil Lawsuit

Women who took Paxil during the first trimester (the first three months of pregnancy) on or before December 2005 and whose babies were born with heart defects (such as a hole in the atrial or ventral septum), persistent pulmonary hypertension of the newborn (PPHN), Omphalocele (an abdominal birth defect), Hydrocephalus (water on the brain) and/or Craniosynostosis (misshapen head) could be eligible to file a Paxil birth defects lawsuit. Women whose babies were born with heart murmurs after Paxil use during the first trimester should also contact an attorney to discuss their legal options.
GlaxoSmithKline has said it will appeal the decision. Meanwhile the company reportedly settled around 800 Paxil birth defects lawsuits for approximately $1 billion in July 2010.

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