We are no longer accepting these cases. This page is for informational purposes only and may be out-of-date.
Did You Take This Medication for Morning Sickness?
We are currently investigating the link between serious birth defects, and the prescription of Zofran® (or ondansetron hydrochloride) to treat nausea and vomiting during pregnancy.
Approved for Chemotherapy and Radiation Therapy Patients
Zofran (or ondansetron), was developed by GlaxoSmithKline to treat nausea and vomiting associated with chemotherapy and radiation therapy. The safety of Zofran for treating nausea and vomiting during pregnancy has never been established. However, doctors began prescribing Zofran “off-label” to treat morning sickness that occurs during pregnancy.
“Off-label”: The use of an FDA-approved drug for an unapproved use.
Before a drug can be approved by the Food and Drug Administration (FDA), the company that created the drug must provide clinical data that the drug is safe and effective. When the FDA approves the drug that means that the benefits and risks have been carefully weighed, there is strong supporting scientific data, and there is approved labeling for healthcare providers on how to prescribe the drug.
The FDA allows healthcare providers to generally prescribe an approved drug for an unapproved use when, in their medical opinion, it is appropriate.
Birth Defects Linked to Zofran Use During First Trimester
Studies have shown a correlation between woman taking Zofran® during their first trimester and the risk of birth defects. Serious Birth Defects Include:
- Structural Heart Defects,
- Atrial Septal Defects (ASD),
- Ventricular Septal Defects (VSD),
- Tetralogy of Fallot (TOF),
- or Cleft Palate
If your baby suffers from serious birth defects, and your doctor prescribed Zofran® (or orndansetron hydrochloride) during your first trimester — you may be eligible for compensation. Contact us to set up a free consultation 877-544-5323.