Topics and Cases - SSRI Birth Defects
Selective serotonin reuptake inhibitors (SSRIs) are used as antidepressants. Drugs included in the SSRI class are Prozac, Zoloft, Paxil, Symbyax, Celexa, Cymbalta, Effexor and Lexapro. However, some studies, including one published in the New England Journal of Medicine, have linked SSRIs to serious birth defects, including persistent pulmonary hypertension of the newborn (PPHN).
Facts about SSRI Birth Defects:
- The New England Journal of Medicine study found that women who took SSRIs during their third trimester were six times more likely to deliver babies born with PPHN—or to have babies that would develop primary pulmonary hypertension—than women who did not take SSRIs during their third trimester.
- Two years before the FDA approval of Prozac in 1998, a 1996 study published in the New England Journal of Medicine revealed that women taking Prozac during pregnancy were two times as likely to deliver a baby with three or more “minor abnormalities” and poorer than average neonatal adaptation.
- In 2004, Health Canada advised of the potential serious adverse effects of SSRI antidepressants on newborns.
- A 2005 Danish study found that infants that were exposed to these antidepressant SSRIs during the first trimester of pregnancy were found to have a 60% higher probability of developing congenital heart defects when compared with infants whose mothers did not take SSRIs.
- A 2007 study in the New England Journal of Medicine found that mothers taking SSRIs in their first trimester double the chance that their child would be born with a septal heart defect.
- A later Danish study released in 2009 seemed to confirm this, though the study asked for additional findings to show whether or not the increased risk existed for all or only some SSRIs.
- Paxil and Effexor were both singled out by FDA in 2005 for warnings associated with these risks.
Litigation News:
- Two years ago, plaintiff Michelle David won a $2.5 million verdict from GlaxoSmithKline after she claimed her 3-year old suffered a life-threatening heart condition as the result of her taking of Paxil during pregnancy.
- By July 2010, over 800 cases had been settled for over $1 billion dollars against GlaxoSmithKline.