Anti-Nausea Medication Linked to Birth Defects
Zofran (ondansetron) is a prescription medication manufactured by GlaxoSmithKline and FDA approved to treat nausea and vomiting in chemotherapy and surgery patients. It works by blocking the body’s chemicals that trigger nausea and vomiting. Due to its effectiveness, Zofran is often prescribed “off-label” for morning sickness; however, it’s never been proven safe for unborn children nor has the FDA approved it for this reason.
Zofran & the 2012 Settlement
While doctors are not prohibited from prescribing drugs “off-label,” manufacturers are prohibited by federal law from promoting their products off-label. In 2012, GlaxoSmithKline entered into a $3 billion settlement with the United States Justice Department to resolve allegations of fraud and illegal promotion of several prescription medications—including Zofran. This was the largest healthcare fraud settlement in U.S. history.
In recent years, several studies have linked the use of Zofran in the first trimester of pregnancy with a significant increase in the risk of birth defects including, but not limited to the following:
- Cleft Lip & Cleft Palate
- Musculoskeletal Defects
- Fetal Growth Restriction
- Craniosynostosis (Skull Deformities)
- Kidney Defects – Including Water Inside the Kidney
- Heart Defects – Heart Murmurs, Atrial Septal Defects & Holes in the Heart
Talk to a Zofran Attorney You Can Trust
At The Simon Law Firm, P.C., we offer compassionate and effective legal guidance to clients who have suffered adverse side effects from the usage of Zofran. We have extensive experience with this type of case. Let us speak to you in a free consultation. You can trust in our firm’s experience, dedication and results.
The Simon Law Firm, P.C. is currently investigating claims of parents who believe exposure to Zofran may have caused their child’s birth defects. If you would like to discuss your case with us call today.
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