Paxil Birth Defects, PPHN and Infant Death

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On September 27, 2005, the FDA issued an alert to healthcare professionals and consumers as GlaxoSmithKline changed their warning label on Paxil (paroxetine) to include the risk of birth defects. These Paxil side effects include Paxil PPHN (Persistant Pulmonary Hypertension in the Newborn). The results of a recent study conducted by the two indicated an increased risk of babies born with Paxil birth defects, specifically cardiovascular defects or congenital malformations, in instances where the mother was taking Paxil during the first trimester of pregnancy.

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Paxil Birth Defects

Paxil, as well as other SSRIs, has been linked to Persistant Pulmonary Hypertension in the Newborn (PPHN) - a devastating condition affecting the heart and lungs of newborn infants. Babies are unable to breath properly due to constricted blood vessels which cut off oxygen to the blood and cause damage to other organs such as brain and kidneys.

Even babies that receive treatment for Paxil PPHN may not recover, and those that do may have long-term breathing problems.

Paxil is used by millions of people worldwide and generates more than $1 billion in annual sales. Paxil has been in the news previously for complaints of severe withdrawal symptoms and risks of Paxil suicidal behavior and increased violence in children and adolescents. Paxil is known as a Selective Serotonin Reuptake Inhibitor (SSRI).

The FDA warns physicians to carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women during pregnancy or while breast-feeding. It is important that all patients are aware of the side effects, risks, and treatment alternatives.

In December 2011, the FDA announced that there is no clear link between PPHN and the use of SSRIs while pregnant. Although two studies suggested a link between the use of SSRIs while pregnant and the development of PPHN, three studies did not support that finding. The FDA is now advising women who are taking antidepressants while pregnant not to stop.

Paxil Prenatal Exposure Risks

Paxil has the potential to influence fetal development, resulting in congenital defects in newborns, and withdrawal symptoms that torment babies for days or weeks after birth.

A study published in the July 2011 issue of Obstetrics & Gynecology suggests that Paxil use during pregnancy is associated with an increased risk of right ventricular outflow tract defects. Although the increased risk is small, researchers warn that physicians should consider other options when prescribing SSRIs to women who are planning on becoming pregnant.

Meanwhile, a study published in the Archives of General Psychiatry (07/11) suggests that use of SSRIs during pregnancy is linked to an increased risk of having a baby born with autism spectrum disorder. Researchers found that the risk doubled when SSRIs were taken during the 12 months prior to delivery and quadrupled when SSRIs were taken during the first trimester.

What is Paroxetine

Paxil (paroxetine) is a class of medicines called selective serotonin reuptake inhibitors (SSRIs). It is used to treat:

Depression

Panic disorder

Social anxiety disorder (SAD)

Obsessive-coompulsive disorder (OCD)

Posttraumatic stress disorder (PTSD)

Generalized anxiety disorder (GAD)

Paxil / Paxil Birth Defect Legal Help

If you took Paxil during pregnancy, and your baby was born with persistant pulmonary hypertension in the newborn (PPHN), please contact a lawyer by clicking on the link below. Your claim will be evaluated at no cost.

Please click here for a free evaluation of your Paxil Birth Defects case

Last updated on Jan-31-12

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