FDA Backs Off Link Between SSRI Antidepressant and PPHN Birth Defects

Federal health regulators have previously warned that the use of SSRI antidepressants during pregnancy may cause a rare heart and lung birth defect, known as persistent pulmonary hypertension in newborns (PPHN), but now indicate that conflicting studies make it premature to reach any conclusions.

On December 14, the FDA issued a selective serotonin reuptake inhibitor (SSRI) drug safety communication, indicating that the drug labels will be updated for the entire class of medications, which includes Paxil, Zoloft, Prozac, Celexa, Lexapro, Sarafem, Symbyax, Luvox, Pexava and Viibryd.

“The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study,” said the FDA this week. “Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.”

The FDA will update warning labels about the potential link between SSRI antidepressants and PPHN to reflect the new data and conflicting results.

PPHN is a birth defect that results in newborns 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.

The FDA told doctors that they must weigh for themselves the potential risks and benefits of prescribing an antidepressant from the SSRI family to a pregnant mother, noting that untreated depression can also lead to poor birth outcomes.

SSRI antidepressants are some of the most widely prescribed drugs in the United States and they have been heavily promoted in direct-to-consumer advertisements. In addition to a potential risk of PPHN, several studies have linked SSRI use during pregnancy to a risk of birth defects or malformations.

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.