New studies show that taking the anti-nausea medication Zofran, widely prescribed to expectant mothers, may place unborn children at a higher risk of developing serious birth defects.

While the drug was FDA approved to give relief to cancer patients with severe nausea, it was increasingly being prescribed “off label” as a way to ward off morning sickness symptoms.

Numerous Zofran lawsuits claim the drug manufacturer had no knowledge that the medication was safe to use during pregnancy yet intentionally marketed the product to pregnant women for morning sickness relief.

Hundreds of Zofran birth defects have been reported by women who took the medication during pregnancy. Some of the most common birth defects include:

• Musculoskeletal defects
• Cleft lip
• Cleft palate
• Congenital heart defects
• Congenital diaphragmatic anomaly
• Kidney defects

Zofran Birth Defect Studies

While a U.S. study published in the New England Journal of Medicine could find no link between Zofran and birth defects, international research shows otherwise.

A Zofran birth defect study performed by Danish researchers followed women who were prescribed Zofran during the first trimester of pregnancy. Researchers calculated that Zofran users have a 20 percent higher likelihood of having a child born with a birth defect when compared to non-users.

An Australian study showed similar results after analyzing nearly 100,000 live births including women who consumed Zofran while pregnant. They, too, showed a 20 percent greater risk for birth defects for Zofran users.

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

GlaxoSmithKline (GSK) faces a growing number of Zofran birth defect lawsuits. 
GSK has received more than 200 birth defect reports from women who took the drug during pregnancy, birth defects that plaintiffs claim could have been avoided had GSK simply conducted clinical trials on pregnant women.

Numerous lawsuits accuse GSK for failing to warn of the potentially life-threatening birth defects especially since the medication carries no caution of fetal harm.

A recent Zofran birth defect lawsuit filed by a mother who had two children born with severe birth defects after fetal exposure to the drug, claims the drug maker GlaxoSmithKline marketed the medication as a safe and effective way to ward off morning sickness without any clinical studies on pregnant women.

The Pennsylvania lawsuit filed by Cheri F. alleges “GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.”

Many Zofran birth defect lawsuits have been filed by parents on behalf of their children to help compensate for the medical treatments needed to manage their conditions.

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.