FAQ's: Paxil

Frequently Asked Questions About Paxil®

• How does Paxil® work?
• What birth defects have been associated with Paxil®?
• Who is at risk?
• What do you do if your baby was harmed as a result of a SSRI drug like Paxil®?

How does Paxil® work?

Paxil® belongs to a class of prescription drugs known as SSRIs (Selective Serotonin Reuptake Inhibitors) commonly referred to as antidepressants.  Serotonin is a neurotransmitter that maintains positive emotions in the brain.  Decreased levels of serotonin can contribute to depression and other related disorders.  Paxil® is thought to treat depression and other related disorders by blocking the reabsorption of serotonin and correcting the chemical imbalance in the brain.

What birth defects have been associated with Paxil®?

Congenital heart defects

In December 2005, the US Food and Drug Administration (FDA) issued a Public Health Advisory concerning Paxil®, based upon two separate studies that showed that exposure to Paxil® during pregnancy posed a serious risk to the fetus and was linked to congenital heart defects.  The most common types of heart defects caused by Paxil® appear to be atrial septal defects and ventricular septal defects, which are abnormal openings in the heart.  Fortunately, these defects are readily treatable in most cases.

Persistent Pulmonary Hypertension of the Newborn (PPHN)

A recent case-controlled study published in The New England Journal of Medicine showed that PPHN was six-times more common in infants whose mothers took an SSRI like Paxil® during pregnancy compared to babies whose mothers did not take an antidepressant. 

PPHN is a rare and life-threatening condition.  PPHN occurs when a newborn’s circulation system does not adjust to breathing after birth.  Normally, when a baby is born, the blood pressure in his lungs falls and there is an increase in blood flow to the lungs, where oxygen and carbon dioxide are exchanged.  The blood then returns to the heart and is pumped back out to the body.  In a baby with PPHN, however, the pressure in the lungs remains high and blood is directed away from the lungs.

The SSRI drugs with the potential of causing PPHN are:

• Celexa® (citalopram)
• Fluvoxamine®
• Lexapro® (escitalopram)
• Paxil® (paroxetine)
• Prozac® (fluoxetine)
• Symbyax® (olanzapine/fluoxetine)
• Zoloft® (sertraline)

Abdominal and Cranial Birth Defects

Information released from the National Birth Defects Prevention Study of Infants indicates that SSRI antidepressants like Paxil® may cause two other congenital birth defects called omphalocele and craniosynostosis.  Omphalocele is an abdominal wall defect at the base of the umbilical cord whereby the baby is born with a portion of the small and large intestine and liver protruding through the defect.  Craniosynostosis is a congenital defect that causes a newborn’s skull to be shaped abnormally, because one or more sutures on the baby’s head close earlier than normal.

Who is at Risk?

Babies born to mothers who took Paxil® (or another SSRI) during pregnancy.

What do you do if your baby was harmed as a result of an SSRI drug like Paxil®?

Read more about Paxil and birth defects.