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The popular anti-nausea drug Zofran is approved for use for cancer and surgery patients undergoing treatments that cause nausea and vomiting. It was never intended for pregnant women, yet for the past numerous years, the medication has been marketed as off-label use for morning sickness. Since then, pregnant women who were prescribed Zofran have been having babies with severe birth defects, one of which may be persistent pulmonary hypertension of the newborn (PPHN).

What is PPHN?

Persistent pulmonary hypertension of the newborn (PPHN), is a severe, life-threatening condition marked by a lack of oxygen, which can affect an infant’s lungs, brain, and heart. About 10% of infants who develop PPHN will die.
PPHN

Prior to birth, a baby relies on the mother for breathing and oxygen, but shortly after birth, begins using his/her own lungs to breathe. After birth, a baby’s blood pressure in the lungs decrease so that breathing on their own is possible. However, infants with PPHN revert back to breathing as they did while in utero, preventing them from breathing properly. Around 1 out of every 500-700 infants born have PPHN.

PPHN Symptoms

The most common symptoms of PPHN include

  • Rapid, quick breathing
  • Rapid heartbeat
  • Skin has a bluish tint
  • Lethargy
  • Sweating
  • Low oxygen levels even after receiving 100% oxygen at the hospital
  • Weak pulse
  • Heart murmurs
  • Hands and feet swelling
  • Liver is larger than average
  • Insufficient blood oxygenation
  • Low blood pressure

Additional Disorders Associated with PPHN

An infant born with PPHN is at risk of developing numerous additional medical conditions, that may affect him/her permanently including,

  • Cerebral palsy
  • Permanent hearing loss
  • Seizures

PPHN Treatment

It’s crucial to make sure an infant is breathing after birth. In addition, doctors need to ensure that the infant’s blood pressure returns back to normal. Therefore, treatment options for PPHN involve using measures to help babies breathe on their own as well as normalizing blood pressure. The most common ways this is achieved is via:

Oxygen Therapy 

Oxygen therapy may consist of an oxygen hood, placing the baby in a high frequency ventilation system, and/or CPAP (Continuous Positive Air Pressure). A CPAP provides 100% oxygen via small tubes inserted into the infant’s nose.

Medications

Medications are used to help normalize blood pressure and to help sedate the baby in order help him/her breathe. Blood pressure and sedation medication are the most common forms of drugs given to babies with PPHN. In some instance, antibiotics and surfactants (a medication that helps improve breathing) may be given.

During treatment, most doctors will discourage you from holding and touching your baby too. Infants will need as little stimulation as possible while undergoing treatment measures.

Important Factors of PPHN Treatment

  • Before treatment, an infant’s body temperature should be stabilized to avoid stimulation.
  • Along with medications, fluids are usually used to help normalize the infant’s blood pressure.
  • High frequency oscillatory ventilation (HFOV) is one form of oxygen therapy used, but physicians haven’t found much more benefit to using it over conventional ventilation.
  • Hyperoxia is a risk when infants undergo oxygen ventilation. However, physicians monitor the baby closely to ensure the best possible outcome.
  • Surfactant therapy (breathing tube inserted into the trachea) is sometimes used on infants with PPHN, but the results of how well this form of treatment works will vary according to each patient’s individual needs.

Zofran and PPHN

According to the National Institutes of Health (NIH), pregnant women who take antidepressants during pregnancy, such as Zoloft and Paxil, have a heightened risk of their infants developing PPHN.

Although studies are still limited (yet ongoing) regarding the risks of PPHN and Zofran, pregnant women have been advised to take extreme caution when taking Zofran while pregnant, as there is a chance that an infant may be at a heightened risk for developing PPHN. Meanwhile, it’s important to understand that the risk is still possible, among other birth defects risks, if you take Zofran while pregnant.

Other causes of PPHN may include:

  • Maternal diabetes
  • Meconium aspiration syndrome
  • Infant stress while still in utero
  • Taking SSRI medications during pregnancy

If You Were Prescribed Zofran While Pregnant

If you took Zofran while pregnant already, and your baby was born with birth defects, you have the legal right to file a Zofran lawsuit against the responsible party. GlaxoSmithKline, the makers of Zofran, have been promoting the use of Zofran for morning sickness as “off-label” use for many years, despite studies indicating that the medication can cause serious medical problems for infants.