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Risk for Paxil Birth Defect Not the Only Concern with Depression

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Washington, DCThe debate over the wisdom in stopping SSRI antidepressants before pregnancy to minimize Paxil side effects impacting the newborn, v. the risk to the mother if her medication is paused, continues to rage as evidenced by a recent report in the Detroit Free Press (3/11/12).

While there remains concern about both the health of the mother and the potential effect of her untreated depression on her unborn child, the fact remains there are equal concerns over the potential for birth defects from selective serotonin reuptake inhibitors like Paxil and the generic paroxetine.

Various studies have linked Paxil to Paxil birth defects such as Paxil heart defects. In 2009, a family won a $2.5 million judgment against GlaxoSmithKline, the makers of Paxil, after their son was born with two holes in his heart. The family launched a Paxil lawsuit. And among the suspected adverse reactions encountered by the fetus after exposure to SSRI medications like Paxil, including PPHN, is a new suspected link to autism—although researchers are quick to point out there is only one study so far to make that connection, and the methodology was apparently suspect.

But there are other Paxil side effects to unborn babies you don't hear too much about. According to the Detroit Free Press, a 2006 Israeli study looked at the potential for withdrawal-like symptoms encountered by a newborn after a pregnant woman opted (or needed) to remain on Paxil throughout her pregnancy to treat her depression.

The Israeli study, published in the Archives of Pediatric and Adolescent Medicine found that one-third of babies born to mothers taking SSRI antidepressants such as Paxil experience withdrawal-like symptoms such as tremors, overall jitteriness, respiratory problems and feeding difficulties. The study found that in most cases the symptoms subsided in a few days, although the first few days of a baby's life are integral.

On the other side of the Paxil FDA debate (for the US Food and Drug Administration always has a role to play in such discussions) are those who fear for the health of a mother attempting to stop needed medication in an effort to protect an unborn child from Paxil birth defects.

There have been cases where babies born to depressed (and untreated) mothers experience low-birth weight, inconsolable crying, sleep difficulties, developmental delays, elevated cortisol and reduced serotonin levels.

However, on the other side of the SSRI and Paxil side effects ledger is the risk for PPHN (persistent pulmonary hypertension of the newborn). The risk is small, according to a study released last month by European researchers and published in the British Medical Journal in February. The risk for PPHN rises from 1.2 babies in 1,000 to 3 in 1,000.

But while the risk is small, that risk of Paxil defect is more than double, when compared to the control group.


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