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.
Paxil Study
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.
Paxil Lawsuit
In October, 2009, a jury awarded a family $2.5 million in a 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 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 there are approximately 600 other lawsuits pending in the US that allege Paxil exposure resulted in babies born with serious birth defects.
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.
Philadelphia, PA: Stories about Paxil side effects are always accompanied by headlines that contains words and numbers—but not necessarily faces. The people behind the headlines are too often overshadowed by the statistics. [ 
Philadelphia, PA: A new study indicates that new mothers who take Paxil may experience problems lactating. The study, published in the February issue of the Journal of Clinical Endocrinology & Metabolism, found that selective serotonin reuptake inhibitors (SSRIs) like Paxil could cause a delay in the start of full milk secretion. [ 
Asbury Park, NJ: A recent study suggesting that selective serotonin reuptake inhibitors (SSRIs) like Paxil afford little benefit to patients with mild to moderate symptoms of depression is not without precedent. Previous studies have come to similar conclusions, leaving some patients to wonder if their use of SSRI antidepressants is warranted. [ 
