Paxil Birth Defects – Increased Risk of Suicide

Antidepressant Drug Paxil Linked to Birth Defects

Paxil Birth Defects may include:


The antidepressant drug Paxil (paroxetine) has shown an increased risk of birth defects if used by pregnant women, particularly during the first trimester of pregnancy. Paxil birth defects include septal heart defects and other congenital abnormalities.

Paxil, approved by the FDA in 1992, is prescribed to treat depression, generalized anxiety disorder (GAD), social anxiety disorder, panic disorder (PD), and obsessive compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). The American Medical Association estimated that over one percent or 40,000 of pregnant women in the US were taking antidepressants in 2006. GlaxoSmithKline, the maker of Paxil, also stated that in that year about 25 percent of prescriptions for Paxil were written for women of childbearing age. Paxil generated about $942 million in sales in 2008 from Paxil.

Paxil belongs to a group of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs). They are designed to relieve the symptoms of depression by blocking the reuptake of the chemical serotonin by certain nerve cells in the brain. With more serotonin in the brain, mood is improved. SSRIs are called selective because they generally affect only serotonin, and not other brain chemicals. However, Maternal Serotonin plays a crucial role in fetal heart, lung and brain development. Because Paxil is known to cross the placenta, the risk of cardiovascular and other congenital malformations may be increased in babies born to mothers who took Paxil while pregnant.

In December 2005 the FDA (US Food and Drug Administration) issued a public health advisory warning of increased risk of Paxil birth defects if used while pregnant. Particularly, during the first trimester of pregnancy.

Paxil Suicide Risk in Young Adults

The FDA and Paxil’s maker, drug company GlaxoSmithKline, notified doctors in 2006 about the antidepressant Paxil and its controlled-release version, Paxil CR, with a warning about suicide risk in young adults. The letter stated that GlaxoSmithKline conducted an analysis of suicidal behavior. The analysis showed a higher frequency of suicidal behavior in young adults with Paxil compared to placebo. This analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with Paxil (paroxetine), a profitable antidepressant, for 15 years, suggest court documents released in January 2008. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

Paxil Birth Defects – PPHN – Spina Bifida

In 1998, a GlaxoSmithKline internal review found an alarmingly high number of Paxil birth defect reports. However, the information was not turned over to the FDA. Early results of two studies showed that women who took Paxil during the first trimester of pregnancy were about two times as likely to have a baby with a heart defect as women who received other antidepressants. Paxil is the only SSRI on the market that is classified by the FDA as a Category D drug. Category D means that studies in pregnant women have demonstrated a risk to the fetus. Most of the heart defects reported were atrial and ventricular septal heart defects (holes in the walls of the chambers of the heart).

Paxil birth defects may include:

  • PPHN – Persistent Pulmonary Hypertension of the Newborn
  • Spina Bifida
  • Heart Defects
  • Lung Defects
  • Neural Tube Defects
  • Cranial Birth Defects

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

Spina Bifida

Spina bifida is a developmental birth defect caused by the incomplete closure of the embryonic neural tube. Some vertebrae overlying the spinal cord are not fully formed and remain unfused and open. If the opening is large enough, this allows a portion of the spinal cord to protrude through the opening in the bones. There may or may not be a fluid-filled sac surrounding the spinal cord. Other neural tube defects include anencephaly, a condition in which the portion of the neural tube which will become the cerebrum does not close, and encephalocele, which results when other parts of the brain remain unfused.

Free Paxil Case Evaluation

You should consider a Paxil Attorney from the Stenger Law Firm, LLC if you or a loved one suffered from any of the above mentioned injuries or death due to Paxil. A Paxil lawyer can help you determine if you are entitled to financial compensation. If you feel you have a potential case for a Paxil Lawsuit, please fill out the form below to have your case evaluated.