The Food and Drug Administration (FDA) recently released all of Zofran adverse event reports which showed hundreds of cases where the anti-nausea medication was named as the suspected cause of birth defects.

Out of the 475 Zofran birth defect reports, the majority of cases referenced congenital heart, respiratory, skull and facial defects.

Zofran is often prescribed to pregnant women “off label” as a way to ward off morning sickness symptoms. However, the Zofran adverse event reports confirm what numerous studies have suggested — fetal exposure to the medication may increase the risk of birth defects.

Zofran Birth Defects

The FDA adverse reports claimed Zofran was the cause of heart defects in 170 individual cases, with 44 references to cardiac septal defects (hole in the heart).

In addition, Zofran was reportedly the cause of 86 respiratory birth defects including neonatal respiratory distress syndrome and pulmonary hypoplasia, which occurs when lungs only partially develop.

The reports further claim that Zofran caused more than 50 cases of skull and facial congenital defects including: cleft palate, cleft lip, microcephaly (infant’s head is abnormally small), and Pierre Robin syndrome (which includes cleft palate, small lower jaw, and a tongue that sits back in the throat that can obstruct airways).

Other adverse fetal outcomes that alleged Zofran was the cause included cases of premature babies, fetal growth restriction, fetal death, stillbirth or spontaneous abortions.

Zofran Birth Defect Studies

For years, Zofran has been the center of medical studies around the world. In 2012, a U.S. study performed by researchers from Harvard, Boston University and the Center for Disease Control and Prevention analyzed more than 10,000 pregnancies and found that women who took Zofran were two-times more likely to have a child born with a cleft palate.

In 2013, a Zofran study performed by Danish researchers reviewed the birth records of 900,000 women and discovered that women who took the anti-nausea drug 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.

In 2014, a study from Sweden reviewed all birth records between 1998-2012 and found that taking Zofran while pregnant increased the risk of congenital heart defects by 62 percent.

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

In the United States, about 1 million pregnant women are prescribed Zofran for morning sickness relief each year. However, multiple Zofran lawsuits claim that drug manufacturer GlaxoSmithKline had no knowledge that the medication was safe to use during pregnancy yet it intentionally marketed the drug to pregnant women.

Zofran lawsuits allege that had GlaxoSmithKline simply performed clinical trials to ensure that the medication was safe for pregnant women, these birth defects could have been avoided. In general, Zofran birth defect lawsuits accuse GSK for failing to warn of the potential life-threatening birth defect risks.

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.