FDA Warning
The FDA has publicly stated that Paxil use during pregnancy "increases the risk for birth defects, particularly heart defects."
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Did you have a child who was born with a heart defect?
Was your child exposed to the drug known as Paxil during pregnancy?
Has your child undergone heart surgery to correct the defect?
Have you been told heart surgery will be necessary in the future to correct the defect?
Has your child undergone a heart transplant?

FDA Warning: Paxil Increases Risk of Birth Defects

The FDA has publicly stated that Paxil use during pregnancy "increases the risk for birth defects, particularly heart defects... Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients... The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect." 1

More recent scientific studies have consistently demonstrated that Paxil increases the risk of heart defects. 2 Another recent study using data from the Swedish Medical Birth Registry concludes that "paroxetine [Paxil] seems to be associated with a specific teratogenic property." 3

Paxil Heart Defects and Paxil Birth Defect Lawsuits

Many hundreds of families have filed lawsuits to recover damages for injuries to their children. If your child was born with a heart defect and you were exposed to Paxil during pregnancy, we may be able to help you protect your child's legal rights. Some of the heart defects we are investigating include:

  • Hypoplastic Left Heart (HLHS)
  • Pulmonary Atresia
  • Tricuspic Atresia
  • Transposition of the Great Vessels
  • Pulmonary Stenosis
  • Atrial Septal Defect (hole in the heart)
  • Ventricular Septal Defect (hole in the heart)
  • Coarctation of the Aorta
  • Tetralogy of Fallot
  • Double Outlet Right Ventricle
  • Persistent Truncus Arteriosus
  • Interruption of the Aorta
  • Double Inlet Left Ventricle
  • Double Aortic Arch

Why Are Legal Claims for Paxil Birth Defects Valid?

Drug companies have a duty to disclose known risks as well as risks they should know about. In a paxil birth defect lawsuit prosecuted by one of our attorneys, a federal court permitted a claim for punitive damages to proceed, holding:

Viewing the record in the light most favorable to the [Plaintiffs], the Court finds that the [Plaintiffs] have shown triable issues regarding their entitlement to punitive damages. The [Plaintiffs] have provided evidence from which a jury could find that in 1993 and 1994, GSK deliberately avoided doing reproductive toxicology studies for Japanese regulators because the studies could provide potentially damaging results for labeling in the United States. They have also provided evidence from which a jury could find that GSK wanted to make sure that the Ingenix study would not look specifically at Paxil. GSK later analyzed the Ingenix data with respect to Paxil at the FDA's request. This analysis contributed to the label change from Pregnancy Category C to D. Drawing all reasonable inferences in the [Plaintiffs]'s favor, a jury could find that GSK acted with reckless disregard for the alleged risks of Paxil by refusing to perform studies which could have revealed potential teratogenic effects. 4

What Can We Do For You?

In a paxil birth defect lawsuit, you may be able to recover compensation for your child. Compensation may include money damages for past and future medical expenses, as well as compensation for pain and suffering.

Please call us at 1-866-252-4762 for a confidential and free initial evaluation of your child's claim or use the form on this page to submit your information electronically. We are a family-run law firm based in Houston, Texas. Your call will be returned promptly by an attorney who can speak with you about your potential claim. Thank you for taking the time to visit our website. We look forward to speaking with you.

Citations:

  • 1 FDA Advising of Risk of Birth Defects with Paxil, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108527.htm
  • 2 Berard A., Paroxetine exposure during pregnancy and the risk of cardiac malformations: What is the evidence? Birth Defects Res A Clin Mol Teratol. 2009 Nov 30;88(3):171-174.
  • 3 Reis M, Kallen B., Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data. Psychol Med. 2010 Jan 5:1-11.
  • 4 Case 4:07-cv-00682-CVE-TLW Document 649 Filed in United States District Court for the Northern District of Oklahoma on 12/14/2009. (internal docket references omitted)
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