Zofran Pregnancy Birth Defect Risks Remain Underappreciated by Doctors

While a growing number of Zofran lawsuits are being filed on behalf of children born with birth defects, the anti-nausea medication continues to be prescribed to pregnant women suffering from morning sickness due to the lack of warnings issued by the drug maker.

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, accounting for a substantial portion of the annual sales for the drug over the past decade.

Several years ago, GlaxoSmithKline was accused of illegally promoting Zofran for off-label use among pregnant women, even though the drug maker never conducted studies to establish that it was safe for unborn children.

Following the publication of independent research that has identified a potential risk of heart defects, cleft palate and other potential congenital malformations, GlaxoSmithKline now faces lawsuits that allege information about the potential Zofran pregnancy birth defect risks was withheld from consumers and the medical community.

Prior to becoming available as a generic in late 2006, Zofran was among the top selling drugs in the U.S., generating $1.3 billion in sales. According to a memorandum sent out in March of that year, the FDA estimated that nearly a quarter of Zofran prescriptions were made by OB/GYNs for use by pregnant women, which was the most frequent use of the drug.

Many doctors continue to assume that Zofran is safe during pregnancy due to prior marketing statements and materials provided by the drug maker.

Zofran Pregnancy Concerns

As early as 2006, a study published by Hong Kong researchers found 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.

Lawsuits filed on behalf of children born with birth defects claim that GlaxoSmithKline should have undertaken a comprehensive study on the potential pregnancy risks of Zofran and warned about the chance that unborn children may develop birth defects.

Plaintiffs claim that the drug maker placed their desire for profits before consumer safety, by essentially turning a blind eye to the mounting evidence in recent years, and by allowing doctors to continue to believe the medication is safe in pregnancy.