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Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery and gastroenteritis. US FDA approved Zofran in January 1991.
While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss.
In the past few years, however, disturbing results from a number of studies surfaced linking Zofran to congenital birth defects. Mothers and families of babies born with serious mental and physical deformities are now pursuing lawsuits against the medication's maker, claiming they were misled and lied to about the drug's risks and safety.
Recent studies have shown that expecting mothers who took Zofran are at a higher risk for delivering children with either of the following birth defects:
- 1. Musculoskeletal anomalies
- 2. Mouth deformity
- 3. Heart defects
- 4. Jaundice
- 5. Kidney malformations
- 6. Cleft lip, Cleft palate, Club foot, webbed toes
- 7. Fetal growth restriction
- 8. Fetal Death
Zofran is labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved the drug was safe, the FDA never gave an approval to market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.
Evidence to be looked for in potential cases
- Usage of Zofran in pregnant females from Pharmacy Records.
- Duration of Zofran in pregnant females from Pharmacy Records.
- Diagnosis of birth related defects in child from Medical Records.
- Treatment required for birth related defects in child.
Medical Record Review and claim validation of Zofran case should take approximately 5 hours in most instances; however, this approximation may vary in cases based on the volume of records.