Persistent Pulmonary Hypertension of the Newborn: The Ongoing Study of the role of Paxil® and the other SSRIs

A baby in the womb does not need to breathe.
Oxygen comes in through the umbilical cord, and while in the uterus, a baby’s circulation bypasses the lungs. When the birth is normal, the baby is born and begins to breathe air and the until-then unused circulatory system ‘wakes up’ and quickly adapts to the new conditions outside the womb. The air is breathed in and the lungs inflate. 

Persistent Pulmonary Hypertension (PPHN): The circulatory system of the baby does not switch to “Breathe” mode.
What happens with Persistent Pulmonary Hypertension is that the circulatory system of the baby does not switch over to now take oxygen from the lungs, and the baby’s blood flow continues to bypass the lungs. The baby breathes, but the oxygen does not reach the bloodstream, and the organs quickly become stressed from lack of oxygen.

What are the Symptoms of Persistent Pulmonary Hypertension?

  • cyanosis – the skin has a blue tinge even with additional oxygen
  • difficulty breathing; flared nostrils of grunting
  • tachypnea – rapid breathing
  • elevated heart rate

PPHN is not common; it occurs in an estimated one out of each 700 births, often as an isolated condition appearing from the time of birth until about twelve hours after birth.

How is the depression/anxiety medication Paxil® implicated in Persistent Pulmonary Hypertension?
As the result of clinical studies, the FDA issued an alert:

Paroxetine (marketed as Paxil®)
FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet)… Neonatal PPHN is associated with significant morbidity and mortality … The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.

Considerations: (also from the alert) Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.

SSRI Drug Names: Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine), Symbyax (olanzepine/fluoxetine), Zoloft (sertraline).

Never stop any medication unless under the specific directions of your fully informed and licensed physician / medical doctor.  As the FDA alert above says, this is a work in progress; the FDA will provide more information as it becomes available and more studies are done. In the meantime, if you or someone you know took Paxil® or one of the SSRI drugs listed above while pregnant, and the baby developed Persistent Pulmonary Hypertension, you may be entitled to compensation. Contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com

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