Zofran, is an anti-nausea medication that is commonly prescribed for post surgical, chemotherapy and morning sickness patients over the past 20 years. According to experts, recent medical studies have found pregnancy side effects that may increase the risk of severe and debilitating birth defects in children.
Patients have blamed GlaxoSmithKline’s failure to adequately research their medication or warn about the risk of congenital malformations. Parents and injured children are filing Zofran birth defect lawsuits throughout the United States who have developed, Cleft Lip, Cleft Palate and severe Heart Defects, especially Atrial Septal Defect and Ventricular Septal Defect.
What is Zofran?
Zofran (generic ondansetron) is a prescription medication approved in 1991 for treatment of nausea and vomiting associated with chemotherapy or following surgery. Over the past decade, it has been widely prescribed off-label for morning sickness in pregnant women, and there is a lack of evidence to prove that it is safe for the unborn child.
Zofran is available in a pill form, oral solution or in an injection. Zofran is a member of a class of drugs known as 5-HT3 receptor antagonists, and works by blocking the actions of serotonin.
Zofran Medical Studies
Several medical studies have highlighted the risk of Zofran side effects, including cleft palate, cleft lip and congenital heart problems, especially atrial septal defects or ventricular septal defects.
Zofran has never been approved for use by pregnant women, and it is widely promoted as a morning sickness drug off label.
In 2006, a Hong Kong study found that Zofran crosses the placenta when taken by pregnant women. The researchers called for more studies to be conducted on the fetal effects of Zofran on unborn children.
In 2011, as part of the National birth Defects Prevention Study, researchers from Boston found an association between the use of Zofran and an increased risk of birth defects. The researchers found that women who took Zofran had more than double the risk of giving birth to a child with cleft palate malformations.
In 2012, a study found that women prescribed Zofran during the first trimester may be 2.37 times more likely to give birth to a child with a cleft palate.
In August 2013, a study was presented that found first-trimester of pregnancy Zofran use may double the risk of having a child with heart problems.
In February 2013, a historical cohort study involving more than 600,000 pregnancies in Denmark was reported to find that there was no link between Zofran and birth defects.
Experts found flaws in the study, that the average gestational age of exposure to Zofran was 10 weeks, so more than half of the women involved took Zofran after the baby was no longer at risk of congenital malformations during the first trimester.
This same data was examined by another group of researchers in August 2013, which involved 900,000 pregnancies over a longer period of time. That study found that Zofran doubled the risk of heart defects and may be associated with a 30% increased risk of birth defects overall.
More recently, several Zofran lawsuits have been filed on behalf of children, alleging that the manufacturer failed to adequately warn about the risks associated with use of the drug during pregnancy.
The latest lawsuit was filed in April by Julia Shonkwiler in the U.S. District Court for the Eastern District of Texas. According to Shonkwiler, her son was born with congenital heart defects and brain defects, which will result in the need for multiple surgeries and most likely result in life long permanent injuries.
Shonkwiler blames Zofran, which was prescribed to treat her morning sickness. The family had no history of congenital birth defects, no genetic abnormalities and Shonkwiler previously gave birth to a child who suffered no birth defects.