Zofran, also known as Ondansetron, was developed by GlaxoSmithKline in the mid-1980s. In 1991, the U.S. Food and Drug Administration (FDA) approved Zofran to treat nausea and vomiting in postoperative and chemotherapy patients. Due to Zofran’s ability to effectively combat nausea and vomiting, doctors prescribe it off-label for severe morning sickness. However, Zofran pregnancy risks revealed in recent studies include cleft palate, cardiovascular damage and other birth defects in babies.
The Andersen Study Uncovers Zofran Pregnancy Risks
Several studies conducted in recent years on Zofran use during the first trimester of pregnancy and birth defect risks. Most prominently is The Andersen Study, which was conducted in August of 2013. Researchers analyzed 903,207 Danish birth records between 1997-2010 in order to determine potential Zofran pregnancy risks for mothers and their unborn children. The study yielded the following significant results:
- 4.7% of women who were prescribed Ondansetron (Zofran) had a child born with some type of congenital malformation
- Zofran use during the first trimester of pregnancy doubled the risk of a child being born with a congenital heart defect
The Andersen Study was one of the first of its kind to warn against women taking ondansetron due to Zofran pregnancy risks.
Zofran Pregnancy Risks: Should You File A Claim?
If you took Zofran during your first trimester and your child was born with a birth defect, you deserve justice. You may have an eligible claim if one or more of the following Zofran side effects occurred: cleft palate/lip, heart defect/damage, kidney damage and club foot. If your child was born with one of these birth defects, you may be entitled to financial compensation. You can get started by completing a free Zofran claim review online to see if your case may qualify. Don’t wait, contact us today! By holding drug manufacturers accountable, you can help women stay informed and potentially avoid having more children born with Zofran-related birth defects.