December 14, 2011 — In a new safety announcement, the FDA wants to inform women that if they take SSRI antidepressant medications during pregnancy, their baby may develop Persistent Pulmonary Hypertension of the Newborn (PPHN) at birth. The FDA is stressing that the findings are conflicting, but they have decided to err on the side of caution and update the safety labeling anyway.
UPDATE: Risk of PPHN Doubled in Women who Took Antidepressants
New research published in January 2012 has found that the risk of having a baby with Persistent Pulmonary Hypertension of the Newborn (PPHN) may be twice as high when women took antidepressants during pregnancy, particularly after the 20th week of pregnancy. The researchers studied 30,000 women who took antidepressants during pregnancy. They found that when mothers took antidepressants, the risk of having a baby with PPHN increased from 1.2 babies per 1,000 live births to 2.1 babies per 1,000 live births.
Studies of PPHN and Antidepressants during Pregnancy
There are two studies that suggest an increased risk of PPHN when mothers use SSRIs during pregnancy. Three studies do not support this association.
This is a safety update following an FDA advisory released in 2006. The advisory followed the conclusion of a research study published in the New England Journal of Medicine, which found that PPHN was six times more likely in babies born to mothers who took SSRI antidepressant medications after the 20th week of pregnancy, compared to babies born to mothers who took no antidepressants. The study was not large enough to make any comparisons between drugs. The study also found that mothers who discontinued their medication were five times more likely to suffer a depression relapse.
Physicians and their patients must weigh the serious risks of depression relapse against the chance of having a baby with PPHN. The FDA recommends that women who are taking antidepressants and are pregnant should not stop treatment.
Why is the FDA concerned about antidepressants and PPHN?
PPHN is a serious, life-threatening birth complication that occurs soon after a baby is born, when its lungs and circulatory system fail to “switch over” to independent life. Before the baby is born, it receives oxygenated blood from the mother’s placenta. An unborn baby actually has holes in the heart so its blood can bypass the lungs. After a baby is born, it can no longer receive oxygen from the placenta, and it must begin breathing on its own. At birth, the baby’s entire heart-lung system undergoes a dramatic change. Normally, the pressure in the lungs undergoes a 10-fold drop, causing the circulatory system to pump blood into the lungs. When the baby breathes, this blood becomes oxygenated. The holes in the heart close within minutes or hours. For a baby born with PPHN, the pressure remains high, and very little blood flows into the lungs, and the holes in the heart remain open. When the baby breathes, the air does not come in contact with enough blood to supply its body with enough oxygen it needs to survive. As a result, the baby turns blue (or “cyanotic”) on its skin, lips, and nails. All babies are born a little blue, as a result of the dramatic circulatory change they experience. A baby with PPHN, however, must receive intensive care. Care may include supplemental oxygen, medications to lower pressure in its lungs, and surgery. Severe cases can result in organ damage, including brain damage, and even death.
The following SSRI antidepressants may cause PPHN:
- Paxil (Paroxetine)
- Zoloft (Sertraline)
- Celexa (Citalopram)
- Prozac (Fluoxetine)
- Lexapro (Escitalopram)
- Symbyax (fluoxetine and olanzapine)
- Wellbutrin (Bupropion)
- Effexor (Venlafaxine)
How do I contact a PPHN Lawyer for a PPHN Lawsuit?
The Schmidt Firm, PLLC is currently accepting antidepressant induced injury cases in all 50 states. If you or somebody you know has had a child with PPHN after taking an antidepressant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our PPHN Lawyer and Antidepressant Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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