Paxil Birth Defect Lawsuit

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.

In July of 2006 the FDA issued a Public Health Advisory indicating that pregnant women who took selective serotonin reuptake inhibitors (SSRI) antidepressants including Paxil, Prozac, Zoloft, Celexa, and Lexapro were at an increased risk of giving birth to a child with the birth defect Persistent pulmonary hypertension (PPHN). This condition is serious for a newborn; without immediate treatment the baby may die due to lack of oxygen reaching the lungs.

This was the second of two warnings the FDA issued on SSRIs over a ten month period. In September of 2005 a Public Health Advisory was issued advising pregnant women who took Paxil, particularly during the first trimester, were at risk of giving birth to a child with birth defects. The possibilities included an abnormally shaped skull, clubfoot condition, defects in the brain and spinal chord, and abdominal wall defects. The most common occurrence associated with Paxil was a newborn with congenital heart defects. The evidence and the FDA warnings that have accompanied medical findings have resulted in multiple Paxil birth defect lawsuits.

Paxil has been under scrutiny for several years because of problems associated with the drug. When the FDA issued its advisory in 2005, part of the notification was that Paxil manufacturer GlaxoSmithKline (GSK) would be required to change the packaging warning on the drug. GSK issued a “Dear Healthcare Professional letter that noted,

“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. 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.”

This is not the only problem the drug company has faced with Paxil. GSK has been sued on several occasions because of suicides allegedly associated with the use of the drug. While these suits have been the subject of medical scrutiny, the linking of Paxil to birth defects is an allegation with much stronger medical data to support it.

The FDA based its request in part on a Swedish study and in part on GSK’s own post-marketing study, which showed an increased risk for newborns with birth defects among pregnant women taking the medication. In their own public notification quoted above, GSK described their results:

“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.”

Paxil continues to be the trigger for multiple lawsuits over birth defects. Some of those cases have been class actions and some have been individual lawsuits. The medication remains on the market however; with all of the adverse publicity hopefully physicians are not prescribing this antidepressant choice to women who are pregnant or are planning pregnancy.

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