Paxil Birth Defects Lawyers

Atlanta, GA: While pregnant women have to sift through the conflicting evidence regarding Paxil birth defects to determine whether or not the risk of reported Paxil side effects outweighs the benefits, news has emerged that at least 1 researcher had ties to GlaxoSmithKline, maker of Paxil, while he was conducting research about the drug. Although financial ties to the pharmaceutical industry are not uncommon for researchers, such a relationship can call into question the unbiased nature of research that is performed, especially when that research shows the positives of the drug involved. [ Read More ]

Montgomery, AL: Unless you have been told that something you did might have caused your child’s birth defects, you probably do not know the overwhelming guilt that mothers whose babies were born with alleged Paxil birth defects feel. These women, who believed that taking the antidepressant was better for the baby than if they did not, now face a lifetime of guilt, a lifetime of thinking that Paxil side effects might have caused their child’s pain. [ Read More ]

Overbrook, KA: Suzy (not her real name pending legal action) was taking SSRI (selective serotonin reuptake inhibitor) antidepressants, namely Paxil and Lexapro, on and off during both of her pregnancies. She now has 2 sons, both with heart defects that may be SSRI birth defects. [ Read More ]

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.

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.