Zofran, also known by its generic name, Ondansetron, was approved by the FDA in 1991. It is commonly prescribed for nausea and vomiting that occurs with cancer patients currently undergoing radiation and chemotherapy. It has as well been prescribed for extreme morning sickness (hyperemesis gravidarum, or HG).
The FDA's label states:
"Pregnancy Category Reproduction studies have been performed in pregnant rats and rabbits at intravenous doses up to 4 mg/kg per day (approximately 1.4 and 2.9 times the recommended human intravenous dose of 0.15 mg/kg given three times a day, respectively, based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. "
However, mounting evidence indicates that taking this drug during pregnancy can have dangerous effects on the unborn child. As a result of dangerous effects being created, a Zofran lawsuit has been launched.
Multiple studies have investigated the link between Zofran (Ondansetron) and birth defects, but the current evidence shows that when a pregnant woman takes Zofran — especially during her 1st trimester — the risk of birth defects may increase.
Zofran birth defects may include:
- Cleft lip
- Cleft palate
- Club foot
- Heart/Septal defects (e.g. a hole in the heart)
- Abnormal heart rhythms
- Craniosynostosis (when the joints between the bones of a baby's skull close prematurely, before the brain is fully developed – causing the head to be misshapen and preventing the brain from growing properly.)
How we can help
At the law offices of Meyers & Flowers, we have the expertise and experience to pursue litigation against large medical firms such as GlaxoSmithKline, PLC. Our long record of excellence includes million-dollar awards on behalf of clients harmed by medical device failure. We are one of the best Zofran birth defect lawyers Chicago has.
If you have been prescribed Zofran and are seeking legal recourse, we can help. We can become your Zofran birth defect lawyer. Your first step is a free consultation with our law professionals to discover if you have a case. It costs nothing to find out your options, and you pay no fees until we win your case. Please call us today to find out more.