Zofran Birth Defect Risk Has Been A Concern For Years

Although Zofran is widely used to combat morning sickness or hyperemesis gravidarum (HG) in pregnancy, a growing number of lawsuits allege that GlaxoSmithKline knew or should have known about the potential risk of birth defects with Zofran for years.

Zofran (ondansetron) is only approved by the FDA for treatment of nausea and vomiting among cancer and surgery patients. However, it is commonly prescribed off-label during pregnancy, resulting in a substantial portion of the annual sales for the drug over the past decade.

Within the medical community it is widely assumed that Zofran is safe during pregnancy, but a number of studies have highlighted potential Zofran pregnancy risks when the medication is used in the first trimester.

GlaxoSmithKline now faces Zofran birth defect lawsuits brought on behalf of children nationwide, which allege that the drug maker withheld important information and warnings from women and the medical community.

Studies Raise Zofran Pregnancy Concerns

As early as 2006, a study published by Hong Kong researchers confirmed that Zofran crosses the placenta in significant amounts when taken by pregnant women.

Researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth defect risks.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

Additional studies have also identified potential Zofran heart defect risks. An August 2013 study that reviewed data on more than 900,000 pregnancies in the Danish Medical Birth Registry found that children may be 2 to 4 times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

Despite the findings of this independent research, GlaxoSmithKline has failed to undertake a comprehensive study on the pregnancy risks or updated the warning label to inform users and the medical community about the findings.

Lawsuits are now being pursued on behalf of children born with birth defects allege that the drug maker placed their desire for profits before consumer safety, by essentially turning a blind eye to the mounting evidence.