Menu

Zofran During Pregnancy: Medical Studies Show Increased Risk of Birth Defects

A normal pregnancy has been repeatedly shown to have lower risks of birth defects than a Zofran pregnancy.


Zofran during pregnancy linked to heart defects, cleft palate, kidney defects and other birth defects:

Zofran Pregnancy Risk Chart updated.001Nearly 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 and no studies have shown Zofran to be safe during pregnancy. 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 these studies have concluded Zofran causes 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
  • 620% risk of kidney obstruction 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 Pregnancy Heart Defects

Zofran Pregnancy Heart Defects

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 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 Levin Simes toll-free at 1-888-426-4156 or by email at info@levinsimes.com.   The experienced lawyers at Levin Simes 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 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 mostcommon 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 were clear and statistically significant: 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. If you used Zofran during pregnancy, especially during the first trimester of pregnancy, and had a child with cleft palate, this study indicates that Zofran likely caused the birth defect.

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.

Cleft palate, even if primarily resolved with a single surgery, can lead to hearing loss, difficulty learning languages, new cosmetic surgeries, and difficulty speaking.  If you or a loved one took Zofran during pregnancy and the child was born with a cleft palate, contact the lawyers at Levin Simes today at 1-888-426-4156 or at info@levinsimes.com.  Read more about Zofran Cleft Palate risks here.

Zofran Kidney Defect Studies:

[UPDATE]: Levin Simes is not currently accepting Zofran kidney defect cases. Please review the information below for your knowledge of the possible side effects of Zofran.

Zofran birth defects were studied by researchers in Australia, particularly the risk of kidney birth defects.   Of the 98,968 pregnancies in Western Australia from the 2002-2005 period, 251 pregnancies involved women using Zofran during the pregnancy.

The results showed that infants born to women using Zofran during pregnancy were at 620% risk of “obstructive defects of renal pelvic and ureter” defects.  They also found the risk of overall birth defects was increased by 20%. This means that children born to women using Zofran during pregnancy were found to have six times the rate of these kidney defects as compared tothose born to women who did not take Zofran during pregnancy.

Obstruction of the kidneys can result in the need for surgical intervention, permanent damage to the kidneys, loss of function of one or both kidneys, and in serious cases even death. Urine blockage in newborns can occur as a:

  • Ureterocele
  • Bladder Outlet Obstruction (BOO)
  • Uretropelvic Junction Obstruction (UPJ)
  • Vesicouretereal Reflux

These conditions can result in hydroureter (swelling of the urethra) and hydronephrosis (swelling of the kidney).  These conditions can damage the future filtering capabilities of the kidney, resulting in lifelong effects for the newborn. A blockage in utero can even result in eventual damage to children’s lungs, as the kidneys in utero help create the amniotic fluid necessary for the child’s lungs to fully develop.

Zofran Lawsuits:

If you or a family member had a child with cleft palate, cleft lip, or heart value defects, please call the experienced attorneys at Levin Simes today toll-free at 1-888-426-4156 for a free consultation. You can also reach out by completing the free consultation form on this page, or contacting us at info@levinsimes.com.