Numerous studies have linked the use of Paxil (paroxetine) during pregnancy to an increased risk of birth defects, especially heart defects. The manufacturer, GlaxoSmithKline, has already paid settlements in hundreds of lawsuits.

What is the problem?

Paxil (paroxetine) is an antidepressant drug that is linked to an increased risk of birth defects. In 2005, the U.S. Food and Drug Administration (FDA) published a warned about the risk of birth defects, especially heart defects.

According to the FDA:

“In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.”

Studies have shown that first-trimester use of Paxil is associated with higher rates of heart defects, especially “hole in the heart” defects like atrial septal defect or ventricular septal defect. Paxil is a Pregnancy Category D drug, unlike most other antidepressants, which are Category C.

Paxil Class Action Lawsuit Settled for $8.5 Million

In February 2013, GlaxoSmithKline (GSK) settled a Paxil class action lawsuit in California for $8.5 million. The class action did not involve birth defects, but resolved allegations that GSK failed to warn doctors that Paxil could be addictive and cause severe symptoms of withdrawal.

Paxil Birth Defect Lawsuit Settlement

GSK has also settled hundreds of Paxil lawsuits involving birth defects. These lawsuits were not part of a class action, but rather individual lawsuits. The first case to go to trial was filed on behalf of Lyam Kilker, a boy who was born with severe heart defects after he was exposed to Paxil in the womb. His family was awarded $2.5 million by a jury in Philadelphia in October 2009. Less than a year later, over 800 additional lawsuits were settled for an average of $1.2 million each, or more than $1 billion total.


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