In December 2005, the Food and Drug Administration issued a warning that children born to women who were taking Paxil while pregnant are at an increased risk of heart defects and other birth defects. The agency stated that women who are in the first trimester of pregnancy or who are thinking of becoming pregnant should not be prescribed Paxil in most cases due to the increased birth defects risk.
The FDA’s Paxil warning was issued after two studies found that women taking the antidepressant during the first three months of pregnancy were twice as likely to give birth to children with heart defects. The most commonly reported heart defects among children born to Paxil users were atrial septal defects (ASD) or ventral septal defects (VSD), holes in the walls that separate the chambers of the heart.
Based on this data, the FDA directed GlaxoSmithKline (GSK), the drug’s manufacturer, to strengthen its pregnancy category from C to D. Category D drugs are those which have been scientifically proven to pose a risk to the fetus when taken during pregnancy.
The FDA issued a second warning in July 2006 after a study was published in the New England Journal of Medicine examining the link between Paxil or similar antidepressants and a type of potentially life-threatening heart defects. Researchers found that women taking Paxil or other selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were six times more likely to give birth to children with persistent pulmonary hypertension of the newborn (PPHN).
In a press release announcing the second warning about Paxil, the FDA advised physicians to discuss the risks of taking Paxil during pregnancy with women who may be prescribed the drug. PPHN—a disease of the heart and lungs—can caused severe circulatory problems which may result in the death of infants with the condition.
GSK is currently facing approximately 600 Paxil lawsuits filed on behalf of children who suffered heart defects or birth defects after their mothers took the antidepressant during pregnancy. Despite the FDA’s warnings about the link between Paxil and heart defects, the agency has not announced any plans to issue a Paxil recall.
If you used Paxil, Zoloft or other antidepressants while pregnant and gave birth to a baby with heart defects or other birth defects, contact the lawyers at Hissey Kientz, LLP to learn more about your rights. You can reach us by our toll-free number at 1-888-776-5552, or by filling out a free case evaluation on this page.