Persistent Pulmonary Hypertension of the Newborn (PPHN)

SSRI antidepressants are linked to many serious, often life-threatening birth defects. Studies have shown that women who take SSRIs such as Zoloft, Prozac and Paxil – are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn, or PPHN, a birth defect that is fatal in about 10 percent of all newborns diagnosed with the condition. Persistent pulmonary hypertension affects the infant circulatory system and deprives vital organs of oxygen. The 90 percent of children who survive are at risk for lifelong complications.

What is PPHN?

Simply put, PPHN describes a birth defect in which the circulatory system fails to make the switch from receiving oxygen in utero to breathing air. In the womb, a child’s lungs do not breathe; instead, babies receive dissolved oxygen via the umbilical cord. Blood distributes this oxygen throughout the body via the ductus arteriosus, a specialized pulmonary artery. Normally, when a baby is born and the umbilical cord is cut, the child takes his or her first breath and pulmonary blood pressure decreases. Within a day, the ductus arteriosus narrows and closes. Blood flow to the lungs increases and oxygen is disturbed throughout the body.

Babies born with PPHN do not experience this normal sequence of events. For them, the ductus arteriosus does not close and blood pressure in the lungs does not decrease. This results in undue strain on the heart, which is working to pump blood through the artery, and also causes blood – and essential oxygen – to bypass the lungs. This sets off a chain reaction of other problems. The baby’s vital organs, including the brain, lungs and heart, are deprived of oxygen.

Medical studies link SSRIs and persistent pulmonary hypertension

After the first SSRI medication received FDA approval in the 1980s, serotonin reuptake inhibitors quickly gained popularity. Today, they are some of the bestselling drugs in the United States, and include some of the nation’s most popular and recognizable prescription medications: Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Celexa (citalopram), Lexapro (escitalopram), and Symbyax (fluoxetine with atypical antipsychotic olanzapine).

Though the medications have clear benefits for many,medical researchers continue to study SSRI side effects. To date, one of the most important studies linking SSRIs to PPHN was published in February 2006 in The New England Journal of Medicine. Researchers concluded that the condition was six times more common in newborns whose mothers had taken these types of medications after the 20th week of pregnancy.

FDA warnings and actions regarding antidepressants

In December 2005, the FDA determined that taking Paxil (paroxetine) during the first trimester of pregnancy could, “increase the risk for congenital malformations, particularly cardiac malformations.” The FDA requested that the manufacturer change Paxil’s pregnancy category from C to D, and add new warnings regarding paroxetine use during pregnancy. Paroxetine is contained in Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.

But it was not until 2006, after The New England Journal of Medicine study results were published, that the medical community – and the world at large – sat up and took notice of the link between using SSRI medications during pregnancy and a diagnosis of persistent pulmonary hypertension. On July 19, 2006, the FDA issued a public health advisory, “Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns.” The advisory promised that, “the FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. In the meantime, the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.”

In December 2011, the FDA issued a drug safety communication, detailing “conflicting findings” regarding any conclusive link.  The FDA stated that no solid conclusions had been reached.

Symptoms of persistent pulmonary hypertension:

Some of the most common signs and symptoms include:

• Blue-tinted skin (cyanosis)
• Breathlessness
• Enlarged liver (hepatomegaly)
• Heart murmur
• Insufficient oxygenation (low blood-oxygen levels)
• Low blood pressure (hypotension)
• Quick breathing (tachypnea)
• Rapid heart rate (tachycardia)
• Sluggish behavior (lethargy)
• Sweating
• Swelling in the hands or feet (edema)
• Weak pulse

Complications and long-term effects

Persistent pulmonary hypertension causes newborns to experience low blood oxygen levels, overworked hearts, respiratory difficulties, and circulatory disorders.

Some of long-term effects and disabilities associated with the condition include:

• Bronchopulmonary dysplasia (scarred, stiff lungs)
• Cerebral palsy
• Heart failure
• Hearing loss (deafness)
• Breathing problems
• Brain hemorrhage
• Seizures
• Kidney failure
• Multiple organ damage

Diagnosis and Treatment

Testing is required to diagnose persistent pulmonary hypertension of the newborn. Imaging and blood tests are the most common tests ordered to confirm a diagnosis, although a doctor may order additional tests to rule out other conditions with similar symptoms.

A doctor who suspects PPHN may order any of the following tests:

• Chest X-rays: To determine if the heart is enlarged or your child has lung disease
• Echocardiogram (heart ultrasound): To determine heart and lung blood flow, and whether there is heart or lung disease
• Ultrasound: To determine whether there is bleeding in the brain
• Arterial blood gas (ABG) test: To measure levels of oxygen, carbon dioxide, and acid buildup in the arterial blood
• Complete blood count (CBC): To measure oxygen-rich red blood cells, infection-fighting white blood cells, and platelets; can determine whether infection or anemia is the cause of illness
• Lumbar puncture (spinal tap): To determine whether infection is present
• Pulse oximetry: To measure blood-oxygen levels and determine whether a child’s organs are receiving sufficient oxygen
• Serum electrolyte tests: To measure the blood-mineral balance

Infants with PPHN are usually treated by a neonatal specialist in a newborn intensive care unit. Treatment may involve maximizing oxygen flow, decreasing lung blood pressure, and increasing blood flow to the lungs and other organs.

Related SSRI side effects

In 2005, the FDA warned that Paxil could increase the risk of heart defects. In 2010, another study was published in the American Journal of Nursing. Among other results, researchers found that babies who are exposed to the antidepressants have a higher risk of many side effects, including atrial septal defects (ASD) and ventrical septal defects (VSD).

Other reports of side effects have been linked with all of the various SSRI drugs.  In addition to PPHN and heart defects, neural tube defects such as spina bifda and anancephaly; cleft palate and lip; clubfoot, and other physical deformities form the basis of many pending legal action all over the country.