The FDA reviewed two studies which found that women who took Paxil in the first three months of pregnancy were 1-1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall.
In December 2005, The Food and Drug Administration (FDA) warned pregnant women and their doctors of an increased risk of heart defects in newborns when taking the antidepressant Paxil (which goes by the generic name paroxetine). The FDA reviewed two studies which found that women who took Paxil in the first three months of pregnancy were 1 1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall.
Along with the warning, the FDA placed the drug into its second-highest category for risk of birth defects, advising patients that "this drug should usually not be taken during pregnancy." In a later warning, the FDA said that Paxil "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."
In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil. As a consequence of these studies, GlaxoSmithKline and the FDA reclassified Paxil as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown that the drug poses a risk to the fetus.
Researchers have been concerned about selective serotonin reuptake inhibitors (SSRIs)—Paxil is in this category—on fetuses for some time, but the FDA's announcement now indicates significant risk, particularly since a large number of pregnant women (estimated as high as 20 percent) suffer from depression and are readily prescribed antidepressants, including Paxil.
In December 2011, the FDA announced that studies gave conflicting results concerning the use of SSRIs while pregnant. Although two studies reportedly suggested a link between the use of SSRIs while pregnant and the development of PPHN, three studies did not support such a finding, making no clear link between SSRIs and PPHN. The FDA has now advised that women who are taking antidepressants while pregnant not stop.
A study from Sweden found that birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all, and that most birth defects involve holes and malformations in the chambers of the heart. The defects often heal on their own, but more severe cases must be surgically repaired.
Since Paxil was approved in 1993, it has become one of the world's most popular antidepressants, taken by tens of millions of patients. According to GlaxoSmithKline, about 25 percent of Paxil users are women of childbearing age, between 18 and 45.
Women who took Paxil during the first trimester (the first three months of pregnancy) on or before December 2005 and whose babies were born with heart defects (such as a hole in the atrial or ventral septum), persistent pulmonary hypertension of the newborn (PPHN), Omphalocele (an abdominal birth defect), Hydrocephalus (water on the brain) and/or Craniosynostosis (misshapen head) could be eligible to file a Paxil birth defects lawsuit. Women whose babies were born with heart murmurs after Paxil use during the first trimester should also contact an attorney to discuss their legal options.
In October, 2009, a jury awarded a family $2.5 million in a Paxil lawsuit filed against GlaxoSmithKline that alleged Paxil was responsible for a young boy's birth defects. The lawsuit claimed that Lyam Kilker, now three years old, suffered from Paxil birth defects, including two holes in his heart, which required surgery. Furthermore, the lawsuit argued that Lyam will require further surgery as he grows and that his heart defects were caused by exposure to Paxil prior to Lyam's birth.
GlaxoSmithKline has said it will appeal the decision. Meanwhile the company reportedly settled around 800 Paxil birth defects lawsuits for approximately $1 billion in July 2010.
Paxil Heart Defect Legal Help
If your baby was born with heart defects, and the mother took Paxil while pregnant, a lawyer may be able to help you. Please click the link below to send your Paxil birth defects complaint to an attorney who will evaluate your claim for free.