Paxil Birth Defects

Paxil Birth Defects Warning By the FDA

In 2005, the U.S. Food and Drug Administration (FDA) alerted doctors to a study which uncovered several major Paxil birth defects seen in babies born to women who took the antidepressant Paxil (Paroxetine) during the first trimester of pregnancy.

Paxil is a potent selective serotonin reuptake inhibitor (SSRI) manufactured and sold by British pharmaceutical giant GlaxoSmithKline. Available since 1992, the medication is used to treat major depression, obsessive-compulsive disorder, panic disorder, and anxiety disorders. When Paxil came on the market, it quickly became one of the largest selling antidepressant drugs and is widely used throughout the world.

According to the FDA in the study of more than 3,500 pregnant women, there were twice as many major Paxil birth defects as other antidepressants. Most of the Paxil birth defects seen in the study were heart related.

The majority of Paxil birth defects cases cited in the FDA’s Paxil birth defects warning involved atrial septal defects (ASD) which affects the tissue that separates the atria and ventral septal defects (VSD). In VSD, holes develop in the walls of the chambers of the heart through which blood can flow from one side of the heart to the other causing a dangerous mix of oxygenated and deoxygenated blood. In some cases, the side effects caused by these Paxil birth defects were so severe that they required multiple surgeries.

Another condition linked to Paxil side effects, omphalocoele, causes internal organs like the intestines and kidney to form in an abdominal sac that remains outside the body.

Due to the results of the study of Paxil birth defects, the FDA required GlaxoSmithKline to add a “black box” warning on the labeling of Paxil.

 

Second Study Warned about Paxil Birth Defects

Several months after the initial FDA warning on the risk of Paxil birth defects, the New England Journal of Medicine published a study linking the antidepressant to PPHN. Children born with PPHN suffer from circulatory problems that can lead to respiratory failure shortly after birth. According to that study, women who used Paxil after week 20 of pregnancy were six times more likely to give birth to a baby with the PPHN Paxil birth defect than women who used no antidepressants during pregnancy.

A PPHN birth defect requires prompt diagnosis and treatment, and the Paxil birth defect of PPHN may be fatal. Babies who survive the initial trauma of a PPHN birth defect frequently suffer permanent hearing and speech damage as well as damage to the brain, which can result in developmental delays and neurological deficits.

Other possible Paxil birth defects and complications include:

·    Difficulties with breathing
·    Seizures
·    Vomiting
·    Low blood sugar
·    Tremor
·    Irritability

Some children of mothers who took Paxil have also been born with severe withdrawal symptoms from the antidepressant. Unfortunately, what happens in pregnant women is that Paxil birth defects occur as the drug passes through the placenta and affects the developing embryo, then the developing fetus and eventually the baby. Paxil birth defects can cause premature birth or even miscarriage.

Because of the risk of Paxil birth defects, the FDA demanded that GlaxoSmithKline, the drug’s manufacturer change the pregnancy category on the drug from C (risk to the fetus cannot be ruled out) to D. The D category means that studies done with pregnant women have shown significant risk of Paxil birth defects to the developing fetus.

Paxil Birth Defects Lawsuits

In October 2009, the first Paxil birth defects case involving a family of a baby born with a hole in his heart was settled with the family being awarded $2.5 million. Since then, there have been hundreds of other cases against GlaxoSmithKline and it is hoped that all families that have suffered as a result of Paxil birth defects are able to receive compensation for their pain and suffering.

If you have taken the drug Paxil while pregnant and your baby developed Paxil birth defects as a result, you have the right to demand justice. The attorneys at D. Miller & Associates, PLLC are experts in getting positive results with Paxil birth defect lawsuits. Your first step is filling out the form requesting a meeting with our Paxil birth defects specialists.