Paxil, Zoloft, LexaPro and Others Linked To Birth DefectsMay 21, 2010 | Parker Waichman LLP
If you are pregnant and taking an antidepressant, you need to talk with your doctor. Some popular antidepressants have been linked to an increased risk of birth defects.
Just this month, a study published in the American Journal of Obstetrics & Gynecology had found that bupropion – sold as an antidepressant under the name Wellbutrin and as a stop-smoking aid under the name Zyban – was also associated with an increased risk of cardiac birth defects.
The study examined 12,700 U.S. babies born between 1997 and 2004. Of those, 6,853 infants had been born with a major heart defect and 5,869 infants with no defect. Among the babies with a defect, 0.5 percent of the mothers reported using bupropion in the month prior to pregnancy or in their first trimester.
Ten cases involved left outflow tract heart defects. A left outflow tract defect disrupts blood flow from the heart’s left chambers to the rest of the body. Those born to mothers who took bupropion in early pregnancy experienced a more than double risk for this specific heart defects versus babies whose mothers did not take the drug. The study found that the most common form of this defect was coarctation of the aorta, or a narrowing of the body’s main artery. In children, this defect necessitates surgical correction.
Since 2005, information has been emerging that certain selective serotonin reuptake inhibitors, or SSRIs, may cause birth defects, including cardiac (heart), pulmonary (lung), neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull) infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus).
In 2005, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory disclosing the results of two studies that examined the effects of Paxil when used by pregnant women during the first trimester of pregnancy. Both these studies concluded that women who used Paxil during the first trimester had a greater risk of delivering babies with a cardiac defect. The common heart defects identified in the studies were atrial and ventricular septal defects. These conditions involve the wall between the right and left sides of the baby’s heart not being completely developed. the finding prompted he FDA to change the pregnancy warning on Paxil from C category to D category, which means that studies in pregnant women have demonstrated a risk of birth defects to the fetus.
In July 2006, the FDA instructed the makers of SSRIs to revise their labels to include information about the life-threatening birth defect of Persistent Pulmonary Hypertension or PPHN. PPHN is a rare and serious respiratory disorder that causes the newborn to not properly adapt to breathing in the outside world and the newborn is thereby unable to receive enough oxygen. That same year, a study in the New England Journal of Medicine showed that babies born to mothers who took SSRI during the second half of pregnancy had a significantly increased risk of being born with PPPHN.