Many women while pregnant experience morning sickness. Some experience it to a greater degree than others. Doctor’s often prescribe a popular anti-nausea medication called Zofran to treat it.

However, Zofran (ondansetron) has been linked to birth defects and serious fetal harm.

The FDA approved Zofran to help patients with nausea after chemotherapy or surgery. Sometimes nausea accompanies cancer treatments and often those who take meds post-op experience nausea. Zofran safely aids those with this kind of nausea.

But GlaxoSmithKline decided that Zofran would be a good medication for pregnant mothers who experience morning sickness also. The FDA had approved Zofran for other nausea causes, but had not approved it for use with pregnant women.

When Zofran lost its patent in 2006, generic ondansetron was often prescribed for morning sickness. Four years later, Novartis and Sandoz began developing an ondansetron drug called Zuplenz that dissolved in the mouth without water.

Zofran Lawsuits

In 2012, GSK was called into court to answer allegations of fraud and illegal promotion of Zofran and other drugs. Allegations included illegal marketing and paying kickbacks to physicians who prescribed the drug.

They were ordered to pay $3 billion as part of the settlement. Last year, Novartis gained the rights from GSK to market Zofran.

As early as 1992, documents show that GlaxoSmithKline knew that Zofran posed a risk to pregnant women. Zofran presented an “unreasonable risk of harm” to fetuses because the drug passes through the placenta.

The many lawsuits against GSK allege that the drug company had a responsibility to make sure that Zofran was safe for patients, that GSK failed to warn the public and that GSK advertised the drug as safe when they knew it was not.

The Zofran lawsuits also claim that GlaxoSmithKline produced a defective drug and failed to properly evaluate all data and safety information on Zofran use for women who are pregnant.

Zofran Birth Defects

Some early studies found no links between Zofran and birth defects, however later studies showed different results.

In a February 2013 study of 2,000 women, no connection was found between Zofran or ondansetron use and birth defects. However, a closer look at the study showed that half of the women studied began taking the drug after 10 weeks of pregnancy.

The fetus is at its most vulnerable state in the first trimester, so Zofran use after that time may not have a significant effect.

Using the same sample, doctors discovered that when they only studied the women who began taking Zofran in the first trimester they found that there was a 30% increased risk of congenital malformations.

In August 2013 a study of 900,000 Danish women found a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”

In essence, babies born to women who took Zofran for nausea and vomiting while pregnant in this study had a doubled risk of cardiac birth defects and a 30% increased risk of overall birth defects.

One researcher notes that there are other drugs available to women who are experiencing nausea and morning sickness while pregnant so there is no need to expose them to a drug, like Zofran, that is has not been proven safe for pregnancy.

Zofran’s safety warnings do not include warnings about the risk of birth defects, especially when taken during the first trimester.

If you or someone you know took Zofran while pregnant and had a child with a birth defect you may have a legal claim.