FDA: Link Between SSRI Antidepressants and Birth Defects Remains Ambiguous

According to a Safety Announcement issued by the U.S. Food and Drug Administration (FDA), recent studies have added significant weight to the link between a distinct group of antidepressants and a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN). Subsequently, pregnant women who receive selective serotonin reuptake inhibitor (SSRI) antidepressant treatment may significantly increase their risk of giving birth to a child with PPHN.

PPHN is a serious and life-threatening lung condition that occurs soon after the birth of the newborn. Children born with PPHN have a propensity to exhibit extremely high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. While relatively uncommon in the medical field, PPHN is severe in nature. This life-threatening condition affects approximately two out of every 1000 babies born in North America. Recent studies, over the past five years, suggest that the use of SSRI antidepressants may increase the risk of a child being born with this catastrophic condition.

Criticism, regarding the use of SSRI antidepressants, originated in 2006 when the FDA issued a corresponding Public Health Advisory. The July 19 Safety Announcement acknowledged that a single study identified potential risks involved with taking SSRI’s during pregnancy. According to the 2006 study, 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.

An FDA Safety Announcement acknowledged more recent study by Källén. According to the study, there is a statistically significant association between SSRI use and PPHN, although the majority of exposures occur during the first trimester of pregnancy. The results of these two studies reporting an increase in risk are interpreted by some to show a strong association between SSRI use in pregnancy and the development of PPHN.

However, as incriminating as the aforementioned studies sounds, three similar studies do not support this association and the potential risk with SSRI use during pregnancy remains unknown. In 2006, Wichman, in association with the Mayo Clinic, conducted a retrospective cohort study of obstetric deliveries within a defined geographic area. According to this study, 16 neonates were diagnosed with PPHN that had not been exposed to SSRIs in utero. Authors of a similar 2009 study found no association between SSRI exposure during the third trimester of pregnancy and PPHN. The most recent study, conducted by Wilson in 2011, identified 58 neonates with PPHN and no SSRI exposure in utero.

The following is a comprehensive lists of the SSRI antidepressants that remain under scrutiny:

  • Celexa
  • Lexapro
  • Prozac
  • Sarafem
  • Symbyax
  • Luvox
  • Zoloft
  • Viibryd

Though conflicting evidence has been presented by both sides, the FDA is still weary of the potential risks associated with SSRI antidepressants when used during pregnancy. At present, the FDA does not find sufficient evidence to conclude that SSRI use in pregnancy causes PPHN, and therefore recommends that health care providers treat depression during pregnancy as clinically appropriate. The FDA will update the SSRI labels as any new data regarding SSRI use and PPHN become available.

Do I Have an SSRI Antidepressant Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in SSRI antidepressant lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has given birth to a child with PPHN and you feel it may be the result of taking an SSRI antidepressant during pregnancy, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.