Zofran (ondansertron) is a prescription medication used to treat or prevent nausea and vomiting in patients after surgery or different cancer treatments. The drug is manufactured and sold by GlaxoSmithKline, and was approved by the FDA in 1991. It works by blocking serotonin in the areas of the brain that trigger nausea and vomiting.
Zofran comes in various forms, including tablets, oral solutions, injections, and more.
Zofran Use Linked to Birth Defects
Zofran has only been approved for use in treating symptoms in patients after chemotherapy, radiotherapy, or surgery. Although the drug was not approved for use in pregnant women, many doctors have prescribed the medication "off-label" to expecting mothers to curb morning sickness. For most of those who experienced birth defects after Zofran use, the drug was prescribed within the first trimester of pregnancy.
Possible Birth Defects Include:
- Mental Problems
- Abnormal Blood Pressure
- Cardiac Defects
- Physical Deformities
- Stomach Problems
- Cleft Lip & Palate
- Club Foot
- and more
There are several case studies that have shown serious risks of birth defects in the babies of users. While GlaxoSmithKline marketed Zofran as safe, these studies have shown that the manufacturer failed to warn about the pregnancy risks associated with off-label use.
Other Harmful Side Effects Associated with Zofran Use
Other Zofran users have experienced serious side effects, including Serotonin Syndrome and QT Syndrome. The symptoms of Serotonin Syndrome include high fever, irregular heartbeats, seizures and unconsciousness. QT Syndrome can be fatal, and is the result of Zofran causing erratic heartbeats.
Your Legal Options
Many mothers and families whose newborns have experienced serious birth defects are pursuing lawsuits against the maker of Zofran. Brayton Purcell LLP attorneys are currently investigating claims against the manufacturer and seller, GlaxoSmithKline. If you or someone you love has given birth to a baby with defects after taking Zofran during pregnancy, do not hesitate to contact our offices today.