About 1 million pregnant women are prescribed Zofran each year as to treat morning sickness. However, according to recent medical studies it is still unclear if fetal exposure to Zofran causes serious birth defects.

In a 2013 study of 900,000 Danish women, researchers determined that Zofran use during pregnancy doubled the risk of having a child born with a heart defect and increased the chance of overall congenital malformations by 30 percent.

However, in a study published in the New England Journal of Medicine (NEJM) that same year, researchers analyzed 2,000 Danish women and concluded that Zofran did not pose a risk to fetuses.

Fifty percent of the women from the NEJM Zofran study started taking the anti-nausea medication at 10-weeks, which some argue placed them outside the time frame in which malformations could occur.

Months later, Danish researchers presented their Zofran research at the International Society of Pharmacoepidemiology. They showed 13 years worth of data that found 58-out-of-1,248 women who took Zofran in the first trimester of pregnancy had a child born with a birth defect.

The researchers believe this is evidence to prove there’s a 30 percent increased birth defect risk linked to Zofran.

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 Overview

Zofran (ondansetron) was FDA approved in 1991 as an anti-nausea medication for cancer patients deal with the side effects of chemotherapy. However, it quickly began being prescribed “off-label” for morning sickness relief.

Zofran manufacturer GlaxoSmithKline (GSK) fell under federal scrutiny for the off-label marketing of the anti-nausea medication in 2012. 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.

Since it’s release on the U.S. market, hundreds of women have reported to GSK that fetal exposure to Zofran causes birth defects. Some of the most commonly reported Zofran birth defects include:

• Cleft lip
• Cleft palate
• Kidney defects
• Musculoskeletal defects
• Congenital heart defects
• Congenital diaphragmatic anomaly
• Intrauterine death
• Stillbirth

Zofran Birth Defect Lawsuits

Nearly 80 percent of pregnant women report experiencing morning sickness symptoms and are often prescribed Zofran to alleviate nausea. However women filing Zofran lawsuits claim they were unaware that the medication could pose a risk to their unborn child.

In general, Zofran birth defects lawsuits allege that GSK should have conducted clinical trials before marketing Zofran for morning sickness relief. Numerous Zofran lawsuits claim GSK failed to warn of the life-threatening birth defect risks of taking Zofran while pregnant, especially since the warning label carries no caution of fetal harm.

Often times, Zofran birth defect lawsuits are filed by parents on behalf of their children as a way to help financially support the continuous medical treatments required to manage their conditions. Parents filing Zofran lawsuits also seek financial compensation for the pain and suffering endured by their child.