About one million pregnant women are prescribed Zofran for morning sickness relief in the U.S. each year.

However, the anti-nausea medication has been the subject of numerous studies after hundreds of adverse event reports have been filed with the Food and Drug Administration (FDA) claiming that the drug causes severe birth defects.

Zofran (ondansetron) was approved by the FDA to give cancer patients relief with severe nausea, but it quickly became a popular “off label” treatment for morning sickness symptoms.

Those who have filed Zofran lawsuits accuse manufacturer GlaxoSmithKline of having no clinical knowledge if the medication was safe to use during pregnancy, yet they intentionally marketed it to pregnant women as a safe and effective morning sickness treatment.

The most commonly reported Zofran birth defects include:

• Congenital diaphragmatic anomaly
• Congenital heart defects
• Kidney defects
• Cleft lip
• Cleft palate
• Respiratory defects
• Intrauterine death
• Stillbirth
• Spontaneous abortions

Of the hundreds of FDA adverse event reports, the most common Zofran birth defect is heart deformities followed by respiratory birth defects including pulmonary hypoplasia, which occurs when lungs only partially develop.

Birth Defect Studies

As reports of Zofran birth defects continue to grow, researchers around the world have chosen to study what side effects the anti-nausea medication has through fetal exposure.

Researchers from Boston University, Harvard and the Center for Disease Control and Prevention studied more than 10,000 pregnancies in 2012 and discovered that women who took Zofran while pregnant were two times more likely to have a child born with a cleft palate.

A recent study performed by Australian researchers who examined 100,000 live births found that those women taking Zofran during pregnancy had a 20 percent increased risk of birth defects when compared to non-users.

In 2013, Danish researchers studied Zofran by analyzing the birth records of 900,000 women and found that those who took the medication while pregnant increased the overall risk of congenital malformations by 30 percent and doubled the likelihood of having a child born with a heart defect.

In a similar study performed in Sweden last year, researchers reviewed all birth records between 1998-2012 and found that pregnant women who took Zofran increased the risk of congenital heart defects by 62 percent.

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 Lawsuits

Numerous Zofran lawsuits have been filed by parents on behalf of their children born with birth defects. In general, these birth defect lawsuits claim that manufacturer GlaxoSmithKline should have conducted medical trials before “off-label” promotion of Zofran as a morning sickness medication.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

If you took Zofran during pregnancy and later had a child born with a birth defect, contact a Zofran attorney to find out if you have legal claim.