(UPDATE: Levin Simes Abrams is not currently investigating new cases regarding Zofran or Ondanestron for failure to warn, when a manufacturer fails to update product labels or drug warning labels to note risks they know or should have known. This page is for informational purposes, please speak with a medical professional regarding any medication change or for medical care.
Department of Justice press release regarding the $3 billion settlement for fraud for illegal marketing, including kickbacks to doctors to prescribe drugs.)
Zofran during pregnancy linked to heart defects, cleft palate and other birth defects
Nearly 80% of pregnant women experience nausea or vomiting, commonly referred to as morning sickness. Seeing an opportunity to profit, GlaxoSmithKline, the manufacturer of Zofran (Ondanestron), illegally promoted the off-label usage of Zofran to pregnant women experiencing nausea, even though this use was never approved by the FDA. Zofran has only been approved for use in chemotherapy and post-surgery patients who experience nausea. Zofran’s manufacturer, GlaxoSmithKline (GSK), illegally marketed off-label use of Zofran and other drugs to the point that Zofran was included in GSK’s $3 billion settlement with the United States Department of Justice for criminal fraud sales tactics.
Due to the prevalence of Zofran (Ondanestron) as an off-label agent used to control nausea and vomiting, researchers around the world began studying Zofran in numerous clinical studies in order to evaluate its risk of birth defects in infants born to women using Zofran during pregnancy. The results of many studies indicate Zofran can cause birth defects, particularly congenital heart defects, cleft palate defects, and kidney defects.
The birth defects linked to use of Zofran during pregnancy include:
- 130% risk of overall birth defects
- 480% risk of AtrioventricularSeptal Defects (AVSD)
- 237% risk of cleft palate defects
- 160% risk of congenital heart defects
- 210% risk of Atrial Septal Defects (ASD)
- 230% risk of Ventricular Septal Defects (VSD)
Zofran Heart Defect Studies
Zofran was investigated by researchers using the Denmark Medical Birth Registry, identifying 903,207 births within the 1997-2010 study period. Of those births, 1,368 women took Zofran during their first trimester. The above chart shows the risks: 210% risk of Atrial Septal Defects, 230% risk of Ventricular Septal Defects, and a 480% risk of Atrioventricular Septal Defects. These congenital defects occurred with such frequency as to raise the rate of total heart defects by 60% to 160% the baseline, and children born to women taking Zofran during the early stages of pregnancy had 30% more birth defects overall, primarily due to these increased heart defects.
The lawyers at Levin Simes Abrams are investigating cases of Zofran pregnancy related birth defects. If you or a loved one has experienced a pregnancy that included a cardiac birth defect, contact us through this page. Our experienced lawyers are available for your free case consultation 24 hours a day, 7 days a week. These defects are serious, usually necessitating surgical intervention, and can lead to serious life-threatening conditions. Not all children born with these defects will survive even with care. Contact Levin Simes Abrams today to discuss your case, and read more about Zofran Heart Defects here.
Zofran Cleft Palate Studies
Zofran during pregnancy was evaluated by researchers from the Harvard School of Public Health, the Massachusetts Department of Public Health, the Slone Epidemiology Center at Boston University, and the National Center on Birth Defects and Development Disabilities. They searched specifically for several of the most common birth defects, including cleft palate and cleft lip. Like the study analyzing the risk of heart defects in a Zofran pregnancy, the results from the data in this study showed Zofran increases the risk of cleft palates.
Infants born to women taking Zofran early during pregnancy are at 237% above the baseline risk for cleft palate, by the results of the study.
The researchers did not stop there, but rather studied the risk of alternatives to Zofran for morning sickness during pregnancy. The study determined that alternative medications did not increase the risk of cleft palate.
Cleft palate is a form of congenital deformity cased when there is abnormal facial development during gestation. The cleft palate may or may not also include a cleft lip. Children born with cleft palates can face a lifetime of surgeries to repair the defect, from an initial surgery 6 months after birth to surgeries as teenagers or young adults to continue to correct defects in the jaw or ears.
(UPDATE: Levin Simes Abrams is not currently investigating new cases regarding Zofran or Ondanestron for failure to warn, when a manufacturer fails to update product labels or drug warning labels to note risks they know or should have known. This page is for informational purposes, please speak with a medical professional regarding any medication change or for medical care.)