Zofran Hole in the Heart

zofran hole in the heartExpectant mothers who use Zofran to control nausea and vomiting in their first trimester of pregnancy may be more likely to give birth to a child with cardiac septal defects, including an atrial septal defect or a ventricular septal defect. At least two recent studies have found that pre-natal exposure to the anti-nausea medication may double the risk of congenital heart abnormalities, including these serious hole in the heart defects

Zofran Lawsuit Investigation

Children born with an atrial or ventricular septal defect may be entitled to compensation from GlaxoSmithKline if their mothers were treated with Zofran in the early months of pregnancy. To find out more about filing a Zofran lawsuit on behalf of your child, please call Bernstein Liebhard LLP today, at (888) 994-5118.

Zofran and Cardiac Septal Defects

Millions of pregnant women have been treated with Zofran to relieve morning sickness, even though the anti-nausea medication has never been approved for this use. Now a growing number of studies suggest that exposure to the drug in the early months of pregnancy may increase the likelihood that a baby will be born with serious birth defects, including a hole in the heart and other cardiac malformations.

  • 2013: A review of data from a Danish Health Registry led by Dr. Jon T. Andersen found that Zofran in pregnancy was associated with a 30% increased risk of birth defects overall, and double the risk of heart abnormalities.
  • December 2014: A study published in Reproductive Toxicology found that children exposed to Zofran before they were born were 62% more likely to develop a cardiac birth defect. The drug was also associated with a two-fold increase in the risk of hole in the heart defects.

What is a Hole in the Heart?

A hole in the heart, or cardiac septal defect, occurs early in fetal development, when the heart separates into its four chambers. The left and right sides of the heart are separated by a wall called the septum. When a hole forms in the septum between the atria (two upper chambers), the baby will sustain an atrial septal defect. A ventricular septal defect forms when a hole develops between the heart’s ventricles (two lower chambers).

Small hole in the heart defects often do not cause any symptoms and resolve on their own, without the need for medical intervention. Large septal defects may require treatment, including surgery to repair the malformation. Symptoms of a Zofran hole in the heart defect may include:

  • Heart murmur
  • Fast, labored breathing
  • Shortness of breath with activity
  • Paleness
  • Failure to gain weight or thrive
  • Sweating while feeding
  • Easily fatigued

Zofran Birth Defects Litigation

Since February 2015, a growing number of Zofran birth defects lawsuits have been filed in courts around the U.S. These include a number of cases that allege Zofran caused hole in the heart birth defects.

  • March 2015: A North Dakota mother claims that her daughter was born with a heart twice as large as it should be, and with extra holes, due to her use of Zofran in the first trimester of pregnancy. Read More
  • February 2015: A complaint filed U.S. District Court, District of Massachusetts, on February 16th seeks compensation on behalf of a child who was allegedly born with several congenital heart abnormalities, including atrial septal defect, right ventricular hypertension and aortic arch hypoplasia, due to the mother’s use of Zofran during the first trimester of pregnancy. Read More

All federally-filed Zofran lawsuits involving cardiac malformations and other birth defects have been consolidated in a multidistrict litigation that is now underway in the U.S. District Court, District of Massachusetts. More than 100 claims were pending in the proceeding as of November 16, 2015. Read More.

Contact a Zofran Lawyer Today

Bernstein Liebhard LLP is offering free legal reviews to the families of children who may have been born with Zofran hole in the heart defects or other congenital malformations that could be linked to this medication. To contact a Zofran lawyer today, please call (888) 994-5118.

  1. TDM Journal Club ( 2013) “Scary Science: Ondansetron Safety in Pregnancy—Two Opposing Results From the Same Danish Registry” http://www.helpher.org/blog/wp-content/uploads/2014/01/2014-Koren-Ondansetron-Safety-TDM.pdf
  2. Reproductive Toxicology (2015) “Use of ondansetron during pregnancy and congenital malformations in the infant” http://www.ncbi.nlm.nih.gov/pubmed/25450422
Last Modified: January 6, 2016

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