New Study: Paxil, Zoloft Increase Risk of PPHN Birth Defects

New 2014 study links SSRI antidepressants like Paxil and Zoloft to an increased risk of PPHN birth defects.

A new study released earlier this month shows an increased risk for developing persistent pulmonary hypertension of newborns (PPHN) born to women who take selective serotonin reuptake inhibitor (SSRI) antidepressants such as Zoloft and Paxil.

The study was published in the British Medical Journal on Jan. 14 by Canadian researchers who found that the risk for developing PPHN went up if the antidepressants were used later in the pregnancy.

PPHN is a very serious and life-threatening lung disease. Babies born with the lung condition have difficulty breathing outside of the womb and may require hospitalization in an intensive care unit while the baby is kept on a mechanical ventilator to keep the baby’s oxygen intake at a healthy level. In severe cases of PPHN, babies may have multiple organ damage as well as brain damage, which can also lead to death.

The researchers explain that “normally the blood vessels in the lungs of the infants relax following delivery, but in persistent pulmonary hypertension of the newborn the resistance in the pulmonary vasculature following birth continues leading to poor oxygenation.”

About 2 per 1,000 babies are born with PPHN.

The researchers gathered data from seven other studies. While the data showed that the risk of babies developing PPHN is still low, it did show that what seemed to put babies at risk for developing the lung condition was being exposed to SSRIs later on in the pregnancy, not at the beginning of the gestational period.

“The absolute risk difference for development of persistent pulmonary hypertension of the newborn after exposure to SSRIs in late pregnancy was 2.9 to 3.5 per 1,000 infants; therefore an estimated 286 to 351 women would need to be treated with an SSRI in late pregnancy to result in an average of one additional case of persistent pulmonary hypertension of the newborn,” the researchers wrote.

In July 2006, the U.S. Food & Drug Administration (FDA)  issued a statement saying that it was “asking sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.”

The announcement was based on a study published in The New England Journal of Medicine that found that “PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.”

However, due to conflicting studies, the FDA withdrew a definitive ruling on SSRIs regarding PPHN in December 2011, saying that the initial warning in 2006 was premature because it was only based on one study.

Some studies have found that there is no link between SSRIs and PPHN and some show that there is, which has been the source of the confusion.

“To date no meta-analysis has been published to summarize the data and potentially help resolve these conflicting findings for clinicians,” the researchers explain, that is until this study, which is “a systematic and meta-analysis to examine” if SSRIs can lead to PPHN.

“We pooled data based on the timing of exposure and where possible assessed for the effects of potential moderating variables, including original study quality and design, and the following known risk factors for persistent pulmonary hypertension of the newborn: preterm birth, congenital malformation, meconium aspiration, maternal obesity, and cesarian section mode of delivery,” the researchers explained.

The researchers conclude that the “meta-analysis suggest the risk for persistent pulmonary hypertension of the newborn is increased with exposure to selective serotonin reuptake inhibitors in late pregnancy; we did not find an increased risk from exposure in early pregnancy.”

If you or anyone you know has had a child born with a birth defect as a result of taking an SSRI such as Zoloft, legal options are available.  Learn more and get a free legal consultation regarding a claim’s eligibility at the Zoloft & SSRI Antidepressant Birth Defect Class Action Lawsuit Investigation.  Experienced legal professionals have access to medical experts to assess whether or not this antidepressant played a role in the development of a serious heart defect in your child, so act now.