Mothers spend their entire pregnancies doing everything they can to ensure that they give birth to healthy children. Unfortunately, research is beginning to demonstrate that mothers may unknowingly harm their children during their pregnancies. According to recent studies, one of the most popular anti-nausea drugs on the market, Zofran, increases the risk that children will be born with birth defects and birth injuries.
Zofran® is commonly used by doctors to reduce nausea in pregnant women, even though the drug has not been approved to treat morning sickness. Prescribing Zofran to pregnant women is an off-label use of the popular prescription drug.
Cory Watson Attorneys is helping families determine whether a Zofran prescription taken during pregnancy is responsible for heart, cleft lip, and cleft palate birth defects in their infants. If you or someone you love gave birth to an infant with a birth defect after taking Zofran, contact our 24/7 team now for a free case review. Call (877) 562-0000 or complete a free online form to get started.
What is Zofran®?
Pharmaceutical giant GlaxoSmithKline (GSK), the manufacturer of Zofran, created the drug to reduce nausea and vomiting in patients after chemotherapy, radiation therapy, or serious surgery. The generic name of the drug is ondansetron and the drug was first approved by the FDA in 1991.
Zofran® and Morning Sickness
Zofran is not approved for use during pregnancy. The FDA classifies Zofran as a Category B pregnancy drug, which means that the safety of Zofran use during pregnancy has not been established.
Illegal Marketing of Zofran®
GSK settled with the Justice Department for $3 billion related to illegal promotion of several of their pharmaceutical products and other violations of federal law. The settlement resolved allegations that GSK promoted Zofran for “off-label” use to treat morning sickness in pregnant women.
Side Effects of Zofran®
Over the past few years, studies have demonstrated that mothers taking Zofran in the first trimester of pregnancy may be putting their babies at an increased risk of birth defects. The first trimester is normally when morning sickness is the worst, thus increasing the likelihood of Zofran being prescribed during this time of crucial fetal development.
A 2013 Danish registry study based on first trimester Zofran exposure found a 30% increased risk of birth defects and a doubling of the risk of a heart defect. Another study in 2012 found a 2.4-fold increase in the risk of cleft lip and palate birth defects with first trimester Zofran use.
Nationwide Zofran® Lawyers
The lawyers at Cory Watson can help mothers who took the anti-nausea drug Zofran and gave birth to children with birth injuries and defects. No matter where you live, and no matter the severity of the birth injury, you and your family may be entitled to financial compensation If your child was injured by the drug Zofran.
Zofran® is a registered trademark of Glaxo Group Limited Corporation and is used here only to identify the product in question.
This law firm is not affiliated with, sponsored by, or associated with Glaxo Group Limited Corporation or the U.S. Food and Drug Administration.