March 30, 2015 — A two year-old girl from Minnesota was born with severe heart defects after she was exposed to Zofran during pregnancy.
Valley News Live reports on the story of Arianah Reisen, a 2 year-old girl who was born with two “hole in the heart” defects. Her heart has already enlarged to twice its normal size, and she is scheduled to undergo open heart surgery in May.
Her mother, Kylee Riesen, said her daughter was unexpectedly diagnosed with life-threatening birth defects after visiting the doctor for a fever. Now, she believes that Arianah’s condition was caused by the anti-nausea drug Zofran:
“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.”
Zofran is not approved or recommended for pregnant women, yet it is commonly prescribed “off-label” for morning sickness. In 2012, the manufacturer of Zofran and the Justice Department agreed to a $3 billion settlement for illegally marketing several drugs, including Zofran in pregnant women.
Now, many pregnant women are filing lawsuits accusing the drug-maker of failing to warn about the risk of birth defects. Several studies published in the last few years indicate that Zofran increases the risk of heart defects, including “hole in the heart” defects suffered by Arianah.
One study, published last year by Reproductive Toxicology, found that first-trimester use of Zofran doubled the risk of “hole in the heart” defects. Overall, the risk of heart defects was 62% higher than normal.
In 2013, another study involving 900,000 pregnancies in Denmark found that Zofran doubled the risk of heart defects, leading to a 30% increased risk of birth defects overall.