What’s the Problem?

July 10, 2015 – For the study, researchers from the Centers for Disease Control and Prevention (CDC), Boston University and the University of British Columbia looked at a cohort of more than 27,000 women who had children between 1997 and 2009.

Use of the selective serotonin reuptake inhibitor (SSRI) drugs Celexa, Lexapro (escitalopram), Zoloft, Prozac or Paxil at least once in the period from one month before conception through the third month of pregnancy was recorded.

Among the cohort, Zoloft was the most commonly used antidepressant, but none of the 5 previously reported birth defects linked to the drug were confirmed. However, the study did find an association between Prozac and 2 congenital malformations – heart wall defects and irregular skull shape. Paxil was also linked to birth defects of the heart, brain, skull and abdominal wall. The relative risk increased 2 to 3.5 times, depending on the defect and antidepressant.

“Continued scrutiny of the association between SSRIs and birth defects is warranted,” the researchers said, “and additional studies of specific SSRI treatments during pregnancy are needed to enable women and their healthcare providers to make more informed decisions about treatment.”

The study was published Wednesday, July 8, 2015 in The BMJ (formerly the British Medical Journal).

What is Paxil?

The orally-administered antidepressant medication Paxil is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, and generalized anxiety disorder. It is a potent and highly selective member of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants. It is one of the oldest SSRIs, on the market since 1992.

Paxil Side Effects

  • Birth defects
  • Sexual dysfunction
  • Insomnia
  • Allergic reactions
  • Seizures
  • Racing or abnormal heart rate
  • Hallucinations
  • Suicidal thoughts or behavior
  • And more

Paxil and Pregnancy

Paxil is classified as a Pregnancy Category D drug, which means that studies in humans have demonstrated a possible risk to a developing baby, but doctors may still prescribe Paxil to a pregnant woman if the benefit outweighs the risk.

FDA Safety Warning for Paxil Birth Defects

In 2005, the U.S. Food and Drug Administration (FDA) published a Safety Communication to warn pregnant women about the increased risk of birth defects from Paxil. The FDA was particularly concerned about two studies — one linking Paxil to a 4% risk of birth defects, and another study linking Paxil to a doubled risk of heart defects.

Paxil Heart Defects

Studies have linked Paxil to a significantly higher risk of heart defects, particularly “hole in the heart” defects, such as atrial septal defect and ventricular septal defect. These life-threatening congenital defects occur when there is a hole in the wall separating chambers on the left and right side of the heart. Approximately 2% of babies exposed to Paxil are born with a heart defect, versus 1% of non-exposed babies.

Paxil Lawsuits

Hundreds of people have already filed Paxil lawsuits and received settlements. The first lawsuit to go to trial, Kilker v. GlaxoSmithKline, was filed on behalf of Lyam Kilker, a child who was exposed to Paxil in the womb and was born with severe heart defects. In October 2009, a jury in Philadelphia awarded his family $2.5 million. Less than a year later, GlaxoSmithKline agreed to pay more than $1 billion to settle approximately 800 Paxil lawsuits for an average payment of $1.2 million.

Paxil Class Action Lawsuit Settlement

GlaxoSmithKline settled a Paxil class action lawsuit in California in February 2012. The $8.5 million settlement resolved allegations that the drug-maker violated the law by failing to warn doctors that Paxil could be addictive and have severe withdrawal symptoms.

Paxil Birth Defects

  • Heart defects
  • Atrial Septal Defect
  • Ventricular Septal Defect (VSD)
  • Tetralogy of Fallot
  • Transposition of the Great Arteries
  • Truncus Arteriosus
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Craniosynostosis
  • Neural tube defects
  • Spina bifida
  • Anencephaly
  • Omphalocele
  • Gastroschisis
  • Pulmonary Atresia
  • Clubfoot
  • Diaphragmatic Hernia
  • Neonatal withdrawal syndrome
  • And more

Paxil Linked to Heart, Brain, Abdominal Wall Defects: BMJ Study

A study published in The BMJ on July 8, 2015 identified a link between Paxil and birth defects of the heart, brain, skull and abdominal wall. In women who took either Paxil or Prozac early in pregnancy, birth defects occurred 2 to 3.5 more frequently compared with women who did not take them. Click here to learn more.

Do I have a Paxil Class Action Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Paxil lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one had a baby with a birth defect caused by Paxil, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit, and we can help.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.