FDA Safety Advisory for Persistent Pulmonary Hypertension of the Newborn | Texas PPHN Lawsuit

On December 14, 2011, the FDA issued a new safety advisory regarding the link between SSRI antidepressant medicine and Persistent Pulmonary Hypertension of the Newborn (PPHN). There is a growing body of evidence linking the maternal use of antidepressants to an increased risk of having a baby with PPHN. Though the results of the studies have been conflicting, the FDA has decided to play it safe. They will be updating the labels on antidepressant medications to include information about the risk of PPHN.

What have the studies found? The data is conflicting: two studies found an increased risk of PPHN in newborns when their mothers took SSRIs during pregnancy. Three studies found no link.

This is not the first time the FDA has made a safety announcement regarding the risk of PPHN and SSRI antidepressants. In 2006, a small research study published in the New England Journal of Medicine found that babies were six times more likely to suffer PPHN when their mothers took antidepressant medications after the 20th week of pregnancy. However, mothers who stopped using antidepressants during pregnancy had a five-fold increased risk of relapsing into depression.

Because the link between antidepressants and SSRIs is inconclusive, but the chance of depression relapse is high for women who stop taking their medications, the FDA is recommending that women who are pregnant do not stop taking antidepressant medications. However, they want women to know the risks to an unborn child, so a woman and her physician can make an informed decision when she is deciding what medications to take during pregnancy. There is growing evidence that links SSRIs to a number of birth defects, including heart defects.

Why is the FDA concerned about PPHN?

Persistent Pulmonary Hypertension of the Newborn (PPHN) is a complication of the birthing process that occurs in about one or two babies for every 1,000 live births. It happens when a baby’s heart-lung system fails to “switch over” from life in the womb to independent life. When the baby is in the womb, it does not need to breathe because the placenta provides it with oxygenated blood, and the heart actually develops with holes that allow blood to bypass the lungs entirely. When the baby is born, however, it must breathe on its own. The circulatory system undergoes a cataclysmic change: the pressure in the lungs drops 10-fold, causing the heart to pump blood into the lungs. The baby is born, takes its birth breath, and the hole in its heart begins to close within minutes.However, when an infant has PPHN, the pressure in the lungs does not drop. As a result, the heart is unable to pump blood into the lungs. When the baby breathes, the oxygen in the air comes in contact with very little blood. The heart-lung system is unable to supply the body with enough oxygen. Babies with PPHN turn blue (“cyanotic”) on their skin, lips, and nails. Though most babies are a born a little blue, a baby with PPHN will remain blue until it receives treatment. The infant must be transferred to an intensive care unit. Treatment may include supplemental oxygen, medications, and surgery if there is an obstruction preventing blood from flowing into the lungs. In severe cases, the oxygen-deprivation associated with PPHN can cause organ failure, including brain failure, and death.

Selective Serotonin Reuptake Inhibitors (SSRIs) and antidepressants have been linked to a variety of birth defects. This class of medications includes the following drugs:

• Paxil, Seroxat (paroxetine)
• Zoloft, Lustral (sertraline)
• Celexa (citalopram)
• Lexapro, Cipralex (escitalopram)
• Symbyax (fluxetine and olanzapine)
• Wellbutrin, Zyban (bupropion)
• Effexor (vanlafaxine)

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