SSRI Antidepressants in Pregnancy Linked to PPHN Birth Defect: Study

A new study by Swedish researchers has found an association between pregnancy use of SSRI antidepressants and persistent pulmonary hypertension in newborns (PPHN), a rare lung birth defect. 

According to research published last week in the British Medical Journal, women who took antidepressants in pregnancy, known as selective serotonin reuptake inhibitors (SSRIs), may face an increased risk of giving birth to a child with PPHN.

SSRI antidepressants are some of the most widely used drugs in the United States, which include Paxil, Prozac, Celexa, Lexapro and Zoloft.

Persistent pulmonary hypertension in newborns (PPHN) is a rare birth defect that results in babies being unable to adapt to breathing outside of the womb. They frequently require intensive care and the use of a mechanical ventilator to help them breathe. Severe cases of PPHN can result in multiple organ damage, brain damage and death.

Researchers collected data on more than 1 million births from Denmark, Finland, Iceland, Norway and Sweden. They found that 0.2 percent of mothers who took an SSRI during either late or early pregnancy gave birth to children with PPHN. Mothers-to-be who suffered from depression but did not take an SSRI also had some increased risk of children with PPHN, but that number appeared to be much lower.

Experts and researchers noted that the study does not prove a causal link between SSRIs and PPHN, and noted that the risk was rare and that it was important for mothers suffering from depression and other mental disorders to get treated.

The study’s findings come about a month after the FDA issued a drug safety communication about the link between SSRI pregnancy use and PPHN. On December 14, the FDA said that it has seen conflicting data on whether the antidepressants caused the birth defect and now believes the association is unclear. That is a reversal of a 2006 decision to place PPHN warnings on all SSRI drug labels.

Several prior studies have linked side effects of SSRI antidepressants in pregnancy to a risk of birth defects and malformations, other than PPHN.

An estimated 800 Paxil birth defect lawsuits have been filed against GlaxoSmithKline over their failure to warn consumers and doctors that use of the antidepressant during pregnancy could lead to PPHN and congenital heart defects in newborns. The lawsuits also claim that the company hid test results and purposefully misled doctors about the risks associated with Paxil, which is one of the most commonly prescribed drugs in the United States.

More recently, momentum has been building for Zoloft lawsuits over Pfizer’s failure to warn about the risk of birth defects when taken during pregnancy. Potential side effects of Zoloft for unborn children have been reported to occur when the drug is taken as early as the first trimester, a time when many women do not even realize they are pregnant.