Zofran, also known by its generic name, ondansetron, is a prescription medication that can be used to treat pregnant women with complaints of nausea and vomiting. Although Zofran is effective in treating nausea and vomiting, recent studies have shown there are serious side effects to both the mother and infant.
Although the U.S. Food and Drug Administration (FDA) is aware that Zofran is associated with increased risks to mother and child, it has not stopped Zofran from being prescribed. Nonetheless, physicians are still under a duty to warn mothers of the increased risk of injury.
The most common birth defects from Zofran are:
- musculoskeletal anomalies
- mouth deformities including cleft palates and lips
- heart defects
- fetal growth retardation, and
Lawsuits have been filed against manufacturer GlaxoSmithKline for injuries sustained by children. The company has readily admitted that using Zofran for nausea and vomiting in pregnant women has not yet been tested despite the company promoting its off label use.
In December 2014, a study was published in the American Journal of Obstetrics and Gynecology highlighting the risks of pregnant women taking Zofran and the various studies performed. One study performed included 900,000 Danish women whose conclusion was that Zofran caused a "2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations." This is obviously a significant risk for unborn children.
Glaxo recently paid $3 billion to settle fraud allegations relating to Zofran. Now, families of babies who have suffered birth defects are coming together in an attempt to get fair compensation for their children because the manufacturer's drug label contains no safety warnings about birth defects.
If a loved one was on Zofran / ondansetron while pregnant and the child was born with birth defects, call us at 315-479-9000 or click the link below to fill out a brief questionnaire. The child may be entitled to financial compensation for their injuries along with payment for medical related expenses to cover any surgeries, therapy, or other medical related treatment.
Contact us today about the Zofran class action lawsuit.