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Paxil Birth Defects Lawyers FAQ

1) What is Paxil?

Paxil (known generically as paroxetine) is an antidepressant in a class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil is used to treat depression, panic disorder, obsessive-compulsive disorder, post traumatic stress disorder, social anxiety disorder and generalized anxiety disorder.

Paxil was approved by the US Food and Drug Administration (FDA) in 1992 and is made by GlaxoSmithKline.

A number of adverse side effects have been linked to Paxil for both the user and, if the user has taken Paxil during the first trimester of pregnancy, for the newborn child. These side effects reportedly include an increased risk of Paxil birth defects, persistent pulmonary hypertension of the newborn and violent thoughts and actions, including suicide.

2) Why are there Paxil lawsuits?

Paxil lawsuits allege that the antidepressant is linked to a risk of birth defects in newborns. Those Paxil birth defects include Persistent Pulmonary Hypertension of the Newborn (PPHN), holes in the heart and malformations of the chamber of the heart. Other infant side effects reportedly linked to Paxil use while pregnant include irritability and difficulty feeding.

3) Are there other serious Paxil side effects?

Paxil has been linked to a risk of suicidal behavior and increased violence in children and adolescents. According to the FDA, analysis of short-term trials found that children and adolescents who used antidepressants had an average risk of suicidal thinking or behavior of four percent, compared with a two percent risk in the group that received a placebo.

4) Has Paxil been recalled?

No. Paxil is still available on the market.

5) What does the FDA say about Paxil?

In December 2005, the FDA issued a Paxil warning indicating that infants exposed to Paxil prior to birth faced an increased risk of heart defects compared to other infants. Furthermore, studies have shown that women who took Paxil during their first trimester were 1.5 to 2 times more likely to give birth to an infant with a Paxil heart defect than women who took a different antidepressant or no antidepressant at all.

Paxil is in FDA pregnancy category D meaning that studies have shown that the medication could pose a risk to the fetus.

The FDA has also ordered a warning for antidepressants, including Paxil, warning about the risk of suicidal thinking and behavior as evidenced by short-term studies.

6) What should I do if I am pregnant or thinking about becoming pregnant and taking Paxil

If you are pregnant or thinking about becoming pregnant and are taking Paxil you should speak with a doctor about your concerns. Do not discontinue any medication without speaking with a medical professional. Although there are side effects associated with taking Paxil while pregnant, there are also risks to having untreated depression while pregnant.

7) Where does Paxil litigation stand?

In October 2009, the family of a young boy born with birth defects, including two holes in his heart, was awarded $2.5 million by a jury. Meanwhile, in July 2010, various news sources reported that GlaxoSmithKline agreed to settle certain Paxil lawsuits that alleged the antidepressant was responsible for birth defects. Approximately 800 lawsuits were reportedly settled for more than $1 billion. GlaxoSmithKline has said the terms of the settlements are confidential.

Other Paxil lawsuits are pending.

8) What is PPHN?

Persistent Pulmonary Hypertension of the Newborn (PPHN, formerly called Primary Pulmonary Hypertension of the Newborn) is a life-threatening condition in which babies have high blood pressure in the blood vessels in their lungs and cannot get enough oxygen in their blood. According to a study cited by the FDA (published in The New England Journal of Medicine, 02/09/06), babies who were exposed to SSRIs after the 20th week of pregnancy were six times more likely to have PPHN.

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Last updated on Jul-22-10
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