Paxil Lawsuit

Paxil Lawsuit Information

If a loved one or someone you know has suffered a birth defect due to the use of Paxil please contact us immediately. We will help you hold accountable the parties responsible for the injury.

Fifteen years ago the first antidepressant classed as a selective serotonin reuptake inhibitor (SSRI) was introduced. That drug was Prozac, and it was a significant – and very popular – addition to treatment options for depression. Since then many SSRIs have been put on the market and today tens of millions of people take them. Since the early part of this decade, however, there have been signs of severe side effects that particularly can endanger pregnant women.

Paxil has been the SSRI most prominent in the news about severe side effects. In 2005 the FDA issued a Public Health Advisory notifying medical professionals and consumers that female Paxil users who became pregnant should consider discontinuing the drug.

Studies indicated that pregnant women who used Paxil, particularly during the first trimester of pregnancy, were at increased risk of giving birth to a child with heart defects. Other birth defects that may be associated with this disease include an abnormally shaped skull, clubfoot condition, defects in the brain and spinal chord, and abdominal wall defects.

Also contained in the Public Health Advisory was a request to Paxil manufacturers GlaxoSmithKline to change the packaging warning on the drug. The FDA’s notification reads, in part: “The FDA has determined that exposure to paroxetine [Paxil] in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations” (emphasis ours). “At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine’s [Paxil’s] prescribing information.”

Part of the information the FDA had considered was research conducted by the drug company. In September of 2005 GlaxoSmithKline issued an advisory announcing the change in packaging information, which contained this comment:

“GSK recently conducted a retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. Preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine [Paxil] as compared to other antidepressants. The types of congenital malformations, which were most commonly cardiovascular, were reflective of those seen in the general population. The most common cardiovascular malformations observed in the study were ventricular septal defects.”

There have been Paxil class action suits and individual Paxil lawsuits filed against GlaxoSmithKline on behalf of mothers who gave birth to children with birth defects, New suits are filed on a consistent basis; in addition, the FDA issued a Public Health Advisory about other SSRI drugs in July of 2006.

That warning declared that women who take virtually any of the SSRI medications are in increased danger of giving birth to a child with neonatal persistent pulmonary hypertension (PPHN). This condition will put a newborn into intensive care; if the situation is not reversed, the infant may die of severe hypoxemia (lack of oxygen in the blood).