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.
Philadelphia, PA: It seems as though GlaxoSmithKline faces an unending stream of people willing to file lawsuits alleging Paxil causes birth defects. Despite the company's insistence that discontinuing Paxil while pregnant is more dangerous than taking it, women whose babies were born with serious birth defects claim that Paxil's side effects are far more dangerous than not taking the drug. [ 
Parkersburg, WV: GlaxoSmithKline faces another Paxil birth defect lawsuit alleging the company's antidepressant caused one boy's serious birth defects. This is just the latest lawsuit GlaxoSmithKline faces that claims the company knew about the risk of serious side effects but did not warn patients. [ 
Ontario, NY: Along with the women who have had babies born with serious birth defects because they were exposed to Paxil prior to birth are women whose babies have not yet appeared to have suffered serious effects. However, many of these women fear that just because problems have not yet surfaced does not mean they will not in the future. They worry that their children will suffer serious side effects later in life because of their exposure to Paxil. [ 
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.