Pregnancy Zofran Use Linked To Increased Risk Of Cleft Palate And Lip Malformations: Study

The findings of a new study indicate that the side effects of Zofran, an anti-nausea drug by GlaxoSmithKline, increase the risk of cleft palate and cleft lip malformations when taken by pregnant women. 

Harvard researchers published a study this week in the Journal of the American Medical Association (JAMA), indicating that use of Zofran during pregnancy increases the risk of oral cleft defects by 24%. However, the study suggests that the drug widely used for morning sickness does not appear to increase the risk of heart malformations.

While Zofran (ondansetron) was originally approved for the use by cancer patients undergoing chemotherapy, it has been commonly prescribed “off-label” for symptoms of nausea and sickness during pregnancy.

In recent years, hundreds of families have filed Zofran birth defect lawsuits, alleging that exposure to the drug during pregnancy caused children to be born with cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other congenital malformations.

This latest study tried to determine the risks of those various types of defects when pregnant women take Zofran.

Researchers conducted a retrospective cohort study involving 1.8 million pregnancies from 2000 through 2013. The women were enrolled in Medicaid from three months before the last menstrual period through one month or longer after delivery. The researchers looked for heart malformations or oral cleft defects among the children of women who took Zofran during the first trimester.

According to the findings, 88,467 women, or just under five percent, were exposed to Zofran during the first trimester of pregnancy. They found no statistical difference in the rate of cardiac malformations between women who did or did not take Zofran during pregnancy. However, children born to women who took the drug were 24 percent more likely to have oral cleft defects.

“Among offspring of mothers enrolled in Medicaid, first-trimester exposure to ondansetron was not associated with cardiac malformations or congenital malformations overall after accounting for measured confounders but was associated with a small increased risk of oral clefts,” the researchers concluded.

Zofran Birth Defect Lawsuits

Given the similar questions of fact and law presented lawsuits over Zofran filed throughout the federal court system, more than 4000 product liability claims are currently centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system.

The court is currently in the process of considering challenges to the admissibility of expert testimony, with Daubert hearings have been scheduled for early next year before the first cases go before juries.

Families each raise common allegations that GlaxoSmithKline knew or should have known about the Zofran pregnancy risks for much longer than the last three years, yet withheld critical safety information, failed to warn doctors or consumers against use of the drug to treat morning sickness, and actively promoted the use during pregnancy, which was never approved by the FDA.

As early as 2006, plaintiffs note that studies have found Zofran crosses the placenta in significant amounts when taken by pregnant women, with Hong Kong researchers concluding that the “developmental significance of this drug exposure requires further investigation.”

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.

In August 2013, another study highlighted a potential risk of heart defects with Zofran, following a review of data involving more than 900,000 pregnancies in the Danish Medical Birth Registry. Researchers found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

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.

In the coming years, GlaxoSmithKline may face hundreds of individual trials if Zofran settlements are not reached for children left with birth defects following exposure to the drug.