Zofran Lawsuit – Information, risks and assistance
There is increasing evidence linking the use of Zofran, a prescription drug, with significant birth defects. (http://www.ncbi.nlm.nih.gov/pubmed/25450422, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874333/, and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/)
Zofran lawsuits claim that the manufacturers of the drug were well aware that Zofran substantially increased the risk of birth defects when given to pregnant women, but the manufacturers neglected to inform the FDA and healthcare providers about it. In addition, the drug should have been subjected to further tests and trials before prescription to patients such as pregnant women.
If you were given Zofran during your pregnancy and your child suffered a birth defect, you and your child may be entitled to compensation. Please contact one of the Zofran birth defect attorneys in this directory for a free claim evaluation.
Zofran is the market name for a prescription drug called ondansetron hydrochloride, which is an antagonist for the serotonin 5-HT3 receptors. Serotonin is an information relay chemical formulated in the brain and primarily acts in the gastrointestinal tract. When the 5-HT3 receptors are activated by specific foreign substances like alcohol, it can cause nausea, vomiting, anxiety and increased exposure to seizures.
Zofran can be taken orally or intramuscularly (injection). It was approved by the FDA to help cancer patients on radiation and chemotherapy. For those patients, it helped suppress nausea and vomiting from the treatments. Although it was never approved for use in pregnant women, it has also been prescribed “off-label” to alleviate morning sickness in early pregnancy. GlaxoSmithKline marketed the off-label prescriptions to combat morning sickness even though it had never been approved for that use by the FDA.
GlaxoSmithKline allegedly even paid doctors to prescribe Zofran to pregnant women with morning sickness. Of course, Glaxo had a significant profit motivation to market the drug to as many people as possible since it brought in millions of dollars every year.
Zofran Warning Labels
In Canada, GlaxoSmithKline is required to warn that ““the safety of ondansetron for use in human pregnancy has not been established,” and “the use of ondansetron in pregnancy is not recommended.” In the US, despite substantial data showing that Zofran use during pregnancy significantly increases the risk of certain severe birth defects, the FDA did not require a warning label for birth defects until November 2013.
Zofran Birth Defects
Common side effects include dizziness and headaches. Some unconfirmed cases also claim damage to the inner ear. Zofran has also been linked to a potentially fatal arrhythmia called torsades de pointes and is known to weaken reaction times and cognitive function. Patients on the drug should therefore avoid operating any machinery.
However, the most significant problems have been birth defects in children born to mothers who were prescribed Zofran to combat morning sickness. The birth defects alleged in Zofran Birth Defect Lawsuits include, among others:
- Atrial Septal Defects (this is a hole in the heart)
- Hypospadias Birth Defects (the opening of the urethra is in the shaft or scrotum rather than at the tip of the penis)
- Orofacial clefts
- Skeletal abnormalities
- Kidney malformation
- Fetal death
What do I do?
If you took Zofran during pregnancy and your child was born with a birth defect, you and your child may be entitled to compensation from the drug manufacturers. Please browse through our directory of defective drug attorneys in your area to find a Zofran injury lawyer near you who can handle your case.