March 30, 2015 — A baby girl must undergo open heart surgery to repair two “hole in the heart” defects her mother believes were caused by Zofran.

Local news Valley News Live spotlighted the tragic case of a family in Dilworth, Minnesota.

At just two years old, a little girl named Arianah was diagnosed with a “hole in the heart” defect. Her heart is also twice the size that it should be. She is scheduled to undergo open heart surgery in May.

Her mother, Kylee Riesen, believes her daughter’s birth defect was caused by Zofran, a medication that is only approved for patients on chemotherapy. Zofran not approved or recommended during pregnancy, but it is commonly prescribed off-label:

“When I was pregnant with Arianah, I was really sick. … They just told me take [Zofran] as needed whenever I felt nauseous, but the whole time I felt nauseous, so I just continued to take it. I thought it was safe.”

Riesen and her daughter are not alone. Lawsuits have already been filed against the manufacturer of Zofran, GlaxoSmithKline (GSK), by women who had children with heart defects after taking Zofran. In 2012, GSK and the Justice Department settled allegations of illegally marketing Zofran to pregnant women.

Now, a growing number of studies are adding evidence that Zofran could pose risks to a developing baby — especially during the first trimester.

In December 2014, a study published in Reproductive Toxicology found that women who used Zofran in the first trimester were 62% more likely to have a baby with a heart defect, and twice as likely to have a baby with a “hole in the heart.”

Another study published in 2013 found that Zofran increased the risk of major birth defects overall by 30%, mostly due to a doubled increased risk of heart defects. Conclusions were published by Dr. Jon T. Andersen and based on data from 900,000 pregnancies in Denmark.


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