Women who took the anti-nausea medication Zofran during their pregnancy and later gave birth to children suffering from cleft lip, cleft palate, or heart defects may choose to sue the drug’s manufacturer in a Zofran birth defects lawsuit.

According to a 2012 Zofran study published by the Center for Birth Defects Research and Prevention, mothers who took Zofran while pregnant, specifically those who took it during the first trimester of pregnancy, doubled their risk of giving birth to a child with cleft lip or cleft palate.

Additionally, a 2013 Zofran pregnancy study reviewed a total of 900,000 children birthed by Danish mothers in order to study the prevalence of Zofran birth defects.

This Zofran birth defects study allegedly concluded that mothers who took Zofran while pregnant were at a 30 percent increased risk of giving birth to infants with several types of birth defects. This Danish birth defects study also noted a doubled risk of Zofran heart defects.

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.”

The FDA originally approved Zofran in 1991 as a nausea treatment for chemotherapy and radiation therapy patients. However, drug manufacturer GlaxoSmithKline has heavily promoted Zofran for off-label use, especially as a morning sickness treatment for pregnant women.

Despite the heavy promotion, GlaxoSmithKline allegedly failed to warn prescribing doctors of the potential for Zofran birth defects if the mother took Zofran during pregnancy.

GlaxoKlineSmith has already faced charges for the unlawful off-label promotion of Zofran and for withholding drug safety information. 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.

Now, the pharmaceutical company faces multiple birth defect lawsuits related to Zofran’s alleged birth defect side effects. The families affected by the company’s negligence, which resulted in children suffering from Zofran birth defects, assert that they deserve compensation for their pain and suffering.

Zofran Pregnancy Research Studies

A team of Hong Kong researchers undertook one of the earliest studies regarding Zofran side effects in 2006. They allegedly discovered that significant amounts of Zofran pass into the placenta when taken by a pregnant woman.

While the resulting  Zofran birth defects seem worrisome, at the time the researchers concluded that “the developmental significance of this drug exposure requires further investigation.”

Since then, researchers have conducted several other Zofran research studies in various countries around the world. Those studies resulted in similar discoveries of Zofran birth defects risks.

Some potential Zofran birth defects reported in various Zofran studies include:

• Cleft lip
• Cleft palate
• Heart defects
• Kidney defects
• Musculoskeletal defects
• Decreased  fetal growth
• Fetal death

Many parents may choose to pursue Zofran birth defects lawsuits or join a Zofran birth defects class action lawsuit in order to gain compensation from GlaxoSmithKline for the pain and suffering their children experienced as a result of the alleged birth defects.

Many of the proposed Zofran lawsuits are seeking payment for the financial hardships resulting from treating and managing Zofran birth defects.