Zofran (ondansetron) is a popular anti-nausea drug often used to deal with morning sickness that comes along with pregnancy, called hyperemesis gravidarum (HG).  

However, in a continually growing number of Zofran lawsuits, plaintiffs allege that drug maker GlaxoSmithKline either knew or should have known about the potential Zofran had to increase the risk of birth defects.

The Food and Drug Administration (FDA) has approved Zofran as an anti-nausea drug for cancer and surgery patients. While, Zofran is commonly prescribed for pregnant women to combat morning sickness, it is considered an off-label treatment because the drug was not approved by the FDA for treating nausea associated with morning sickness.

However, a substantial portion of the drug’s annual sales in the last 10 years has come from morning sickness treatment.

But a number of studies have detailed potential pregnancy risks when Zofran is used early in the pregnancy, especially in the first trimester, which is also when morning sickness is typically the most severe. 

Plaintiffs involved in Zofran birth defects lawsuits cross the United States allege that the drug maker withheld information and warnings within its knowledge about birth defects from women and the medical community.

Researchers in Hong Kong found in 2006 that, when taken by pregnant women for morning sickness, a significant amount of Zofran crosses the placenta from mother to child.

While these researchers concluded that the “developmental significance of this drug exposure requires further investigation,” no warnings about even the potential Zofran birth defect risks have been given, and millions of women continue to be prescribed this medication which may somehow affect their child.

In 2011, a published study reached the conclusion that the children of women who used Zofran for their morning sickness may be 2.37 times more likely to be born with a cleft palate. This condition leaves children not only with a severe facial deformity, but may cause problems with speech and feeding.  

Other studies, published in 2013 and 2014, found that there is a significant increase of risk for children whose mothers used Zofran early in pregnancy to be born with dangerous heart defects.

The 2013 study found that children whose mothers used Zofran may be between two and four times more likely to develop a heart condition known as septal defect, which involves holes in the heart.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran birth defect awsuits are being pursued on behalf of children born with birth defects, alleging that GlaxoSmithKline has willfully disregarded both evidence of potential risk and the health and safety of unborn children.

If you or someone you know has used Zofran as an anti-nausea drug during pregnancy, and has subsequently given birth to a child with birth defects, you may be able to file a Zofran lawsuit against GlaxoSmithKline for failing to adequately warn or inform you of the potential risks to your child.