Zofran (ondansetron) is an anti-nausea medication made by GlaxoSmithKline (“GSK”). In 1991, the Food and Drug Administration (“FDA”) approved it for chemotherapy patients with severe nausea and vomiting. However, it has been prescribed “off label” for pregnant women suffering from morning sickness even though the FDA never approved Zofran for use by pregnant women.
Studies have noted a link between Zofran use in the first trimester and birth defects such as heart defects and cleft palate. In recent years, studies have found evidence that Zofran is not safe to use during pregnancy:
- In a study involving 900,000 pregnancies in Denmark from 1997-2010, the use of Zofran was linked to a 30% increased risk of birth defects. Birth defects occurred in about 4.7% of babies exposed to Zofran in the first trimester.
- In 2012, a study published in Birth Defects Research reported that babies exposed to Zofran in the first trimester were 2.4-times more likely to be born with cleft palate.
- In 2013, BioMed Research International published a study linking the use of Zofran with a 20% increased risk of birth defects and higher rates of premature birth.
- In 2014, a study published in Reproductive Toxicology found a doubled risk of “hole in the heart” in babies exposed to Zofran.
On June 17, 2015, a lawsuit was filed by the parents of an infant, Molly Regan who died of heart defects after her mother took Zofran. The lawsuit was filed on behalf of a baby girl who was exposed to Zofran in the womb. Her mother used Zofran for the treatment of morning sickness.
The child was born in March 2006 with a heart defect, but only survived for three days. The lawsuit was filed in the U.S. District Court for the Northern District of Ohio against GSK. It is alleged that the drug-maker was negligent for marketing Zofran to pregnant women without warning them about the possible risk of birth defects:
“GlaxoSmithKline actively concealed information and actively misled the [parents], their physician, the medical community in general, the public at large, and federal regulators regarding Zofran’s propensity to cause birth defects and its appropriateness for use by pregnant mothers.”
In June 8, 2015, a lawsuit was filed against GSK by two other women who were prescribed Zofran for the “off-label” treatment of morning sickness and had babies with heart defects. The lawsuit was filed in the U.S. District Court for the Western District of Louisiana. One mother asserts that she started using Zofran in January 2010 to prevent nausea and vomiting in her first trimester of pregnancy. Six months later, she gave birth to a baby girl who was born with “hole in the heart” defects and needed surgery. Her heart defects included ventricular septal defect and atrial septal defect.
On April 8, 2015, the parents of a girl who was born with a cleft lip and palate after being exposed to Zofran have filed suit against GSK in federal court in Montana for failing to warn about the risks. In 1998, the child, M.M., was born with birth defect after her mother used Zofran during her first trimester of morning sickness. According to the complaint, “M.M. has had to undergo ten surgeries to try and correct her cleft lip and palate.” The complaint alleges that her birth defect impairs her development and enjoyment of a normal life at home and at school.