In the pharmaceutical industry, drugs that are FDA-approved for one purpose may be repurposed to treat conditions outside the scope of the FDA’s original approval. In such cases, the drug is said to be used for “off-label”, meaning the drug is treating a condition other than the condition officially approved by the FDA.
In some cases, off-label treatments can cause devastating injuries to patients who take the drugs for off-label purposes. Patients who used Zofran for off-label purposes may have experienced these harms firsthand.
If you or a loved were injured after taking Zofran for off-label purposes, discuss your case with Jackson, Mississippi Zofran lawyers since you may be entitled to legal compensation.
What Is Zofran?
Zofran’s original purpose as outlined by its FDA approval was to treat cancer patients undergoing radiation and/or chemotherapy. Zofran (ondansetron) helps alleviate the symptoms of nausea and vomiting that result when cancer patients undergo repeat courses of cancer therapy.
The drug maker, GlaxoSmithKline (GSK), never sought FDA approval nor received FDA approval for any other forms of treatment. However, the drug has been used to treat morning sickness in pregnant women. Since morning sickness also causes nausea and vomiting, the thought was that the drug would curb nausea in the same way it worked for cancer patients. However, studies and research indicate that off-label Zofran use during pregnancy may lead to birth defects and other harms.
Potential Risks and Dangers of Off-Label Zofran Use
In 2004, a study found that using Zofran during pregnancy could be linked with a birth defect known as hypospadias. Hypospadias is a urethra birth defect in males where the urinary opening is not at the typical head of the penis. Surgery is usually the recommended treatment for this defect, and alarmingly, GSK did not investigate this correlation.
Other studies show similarly troubling findings. Another study conducted by Swedish researchers determined that Zofran use during pregnancy may double the risk of septal heart defects, also known as “hole in the heart” defects. Additionally, Zofran has been shown to potentially double the risk of cleft palate defects, and an Australian study found that Zofran use may dramatically increase the risk of kidney defects.
While more evidence and research is needed to conclusively determine Zofran causes birth defects, the potential risk of Zofran causing birth defects has led to hundreds of pending Zofran lawsuits.
GSK has been hit with several prominent lawsuits for the way they marketed Zofran to pregnant mothers. Discovery in these cases have revealed that GSK did not conduct a single clinical trial before marketing the drug to pregnant women.
Because of their unethical marketing tactics, GSK agreed to settle with the United States Department of Justice and pay $3 billion to resolve charges of fraud and the failure to report safety data.
Even now, hundreds of Zofran birth defect lawsuits are currently pending. There have been no settlements as of yet since the cases have only been recently filed, and discovery is still ongoing in many of the cases. If you believe your child’s birth defect is based on Zofran use and live in Mississippi, talk to a trusted Zofran attorney in Mississippi to seek the answers and justice you need.
Possible Zofran birth defects include, but are not limited to:
- Heart Defects and Heart Murmur
- Kidney Defects
- Cleft Palate
- Musculoskeletal Defects
- And More
If you need a Zofran lawyer in Jackson, Mississippi, our trusted team at ‘Maggio | Thompson, LLP is here to help. Contact us to talk with a proven Zofran attorney in Mississippi to get answers, justice and the potential for deserved compensation based on your child’s unnecessary birth defects.