As the Zofran litigation continues, new evidence has surfaced suggesting that the anti-nausea medication could cause birth defects. A recently published study reported on the alleged correlation, adding to the mounting evidence against GlaxoSmithKline (GSK).

The study was published in the February 2015 issue of Clinical Pharmacology and Therapeutics, and involved 40 pregnant women and 20 non-pregnant women.

Each of the pregnant women were prescribed Zofran as a possible treatment for neonatal abstinence syndrome. The researchers then collected blood samples from the umbilical cords and infants after birth. Researchers found that Zofran had put more stress on the infants’ biological structure as compared to the mothers, while non-pregnant women showed the least stress.

The study was published in the midst of intense litigation over GSK’s alleged knowledge of the Zofran birth defect risk and failure to warn consumers.

Zofran is a very powerful anti-nausea medication that is only meant to treat patients going through chemotherapy, radiation therapy, and intense surgery. However, for years physicians have prescribed Zofran to pregnant women who are suffering from morning sickness.

While it is not illegal for a physician to prescribe a medication for off-label purposes, it is not permissible for pharmaceutical companies to advertise the drugs for such purposes.

Overview of Zofran Birth Defects Allegations

GlaxoSmithKline allegedly promoted Zofran for off-label purposes once they discovered how lucrative the morning sickness market was.

Morning sickness is a common ailment during the first trimester, due to hormonal changes in women’s bodies. It is most common and can often be severe in first-time mothers.

According to the FDA, Zofran is classified as a Pregnancy Category B drug, which means that animal studies revealed no harm to the fetus from the drug, but there have been no adequate studies conducted on pregnant women. GSK allegedly did not mention the lack of adequate studies or FDA approval in its advertising.

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.

Currently, the drug company is facing individual lawsuits from mothers who took Zofran while pregnant and gave birth to children with birth defects allegedly caused by the drug.

According to court documents, at least two Zofran lawsuits have been filed in federal court so far in 2015. The first was filed in Pennsylvania on Feb. 12, 2015 by a woman who claims the drug caused two of her children to be born with severe birth defects. She used Zofran for both of her pregnancies, allegedly resulting in serious cardiac complications in her children.

The second Zofran lawsuit was filed in Massachusetts on Feb. 16, 2015 by a woman who alleges that her Zofran prescription caused her child to be born with congenital heart problems. GSK representatives deny all allegations pertaining to the alleged side effects.

Legal experts are expecting many more similar lawsuits to be filed against GlaxoSmithKline due to Zofran’s popularity and the company’s effective promotions. The FDA warns against prescribing Zofran to pregnant women, suggesting that physicians prescribe other drugs for that treatment purpose.