Troubling evidence suggests the drug Zofran may be associated with an increased risk for birth defects such as heart defects and cleft lip and palate.
If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, contact our dangerous drugs immediately. You or your child may be entitled to compensation through a Zofran lawsuit.
WHAT IS ZOFRAN?
Zofran is an anti-nausea drug sold by GlaxoSmithKline (GSK). It was approved by the U.S. Food and Drug Administration (FDA) in 1991 for the prevention of nausea and vomiting in patients recovering from chemotherapy or surgery.
It was never approved by the agency to treat morning sickness.
However, Zofran is often used off-label to treat cases of extreme morning sickness, and may cause severe birth defects such as heart malformations, oral clefts and other serious, long term complications.
STUDIES DOCUMENT ZOFRAN RISK TO BABIES
The FDA is investigating two side effects of this dangerous drug including serotonin syndrome and irregular heart rhythm that could lead to deadly cardiovascular events.
In addition, several studies have identified a link between ondansetron, the active ingredient in Zofran, and an increased occurrence of congenital defects.
BIRTH DEFECTS LINKED TO ZOFRAN
Since most women experience nausea and vomiting during the first trimester, they would be taking the drug at the same time the fetus is most vulnerable to developing malformations and deformities.
Studies suggest that babies exposed to Zofran in the first trimester of pregnancy are at an increased risk of a variety of birth defects.
This list includes (but is not limited to):
- Cleft lip and cleft palate
- Heart defects
- Poor growth in the womb
- Serious pregnancy complications
If your child was born with any of these birth defects after the mother took Zofran during pregnancy, a Zofran lawsuit can help you recover compensation for medical expenses, pain and suffering, and more.
GLAXO PAID $3 BILLION TO SETTLE FRAUD ALLEGATIONS INVOLVING ZOFRAN
Off-label means a drug is used for a condition or age group for which it hasn’t been approved. To clarify, while a doctor has the authority to prescribe a drug off-label, the manufacturer does not. To that end, promoting and marketing a drug to doctors and healthcare professionals for unapproved indications is illegal.
Despite a lack of evidence establishing the safety of Zofran and pregnant women, lawsuits allege that GlaxoSmithKline actively promoted such off-label use and withheld important warnings about the potential link between Zofran and birth defects.
Manufacturer GlaxoSmithKline paid about $3 billion to resolve allegations of fraud involving Zofran, including failure to report safety data and the promotion of off-label uses involving the drug.
LEARN ABOUT FILING A ZOFRAN LAWSUIT TODAY
Families depend on pharmaceutical companies and medical professionals to rigorously test and ensure the safety of products they sell. If you think Zofran is responsible for your baby’s defect, you may be owed compensation. While compensation cannot take back what has happened, it can alleviate any financial burden this has placed on your family and ensure that your baby gets the best care moving forward.
If you or someone you know had a child with a birth defect following early prenatal exposure to Zofran, contact us today to learn more about filing a Zofran lawsuit. Our experienced team of personal injury lawyers offers free consultations and does not charge any legal fees unless you recover compensation.