Whenever a manufacturer markets a medication as safe for its intended use, consumers should be able to trust that the drug is, in fact, safe. This should especially be true for pregnant women who are not only concerned about their own health but also the health of their unborn child. Unfortunately, many children were born with severe birth defects as a result of taking the pharmaceutical Zofran or similar drugs Zuplenz and the generic form of ondansetron.
Zofran was initially designed and approved by the Food and Drug Administration (FDA) to help relieve nausea and vomiting in cancer patients caused by chemotherapy or post-operative pain medications. However, the original manufacturer, GlaxoSmithKline, began marketing the drug to physicians to prescribe for pregnant women struggling with nausea from morning sickness. However, the drug had not been approved by the FDA for pregnant women and Glaxo did not adequately test the effects of the drug on pregnant women.
Devastating effects of Zofran and related drugs
Research indicated that Zofran passes into the uterus and through the placenta, thereby affecting the health and development of the unborn child. Previous legal claims have exposed that Glaxo knew of these risks yet continued marketing the pharmaceutical as safe for pregnant women. As a result, many women who took Zofran while pregnant have had children born with severe birth defects, including the following:
- Holes in the heart and other heart defects
- Craniosynostosis and other skull deformities
- Cleft palate or cleft lip
- Club foot
- Other physical and potentially disabling defects
Many of the defects in children caused by Zofran require extensive medical and surgical treatment and some leave children permanently impaired.
Cases against Glaxo and other manufacturers
GlaxoSmithKline has already been taken to court numerous times over the unapproved and unlawful promotion of Zofran. The company agreed to pay $3 billion in a settlement with the Department of Justice for both civil and criminal fraud claims regarding Zofran and other drugs sold by the Glaxo. In addition, many mothers and children harmed by Zofran have filed lawsuits against the company to hold Glaxo accountable for their injuries. If you believe your child has birth defects due to Zofran or other drugs, call us at (888) 454-0801 for help today.