Zofran is the brand name for the generic medication Odansetron Hydrochloride. It is manufactured by GlaxoSmithKline (GSK) and is available as an oral tablet, as an injection for intravenous use, as an oral solution and as an oral disintegrating tablet.
In January 1991, the U.S. Food and Drug Administration (FDA) approved Zofran to prevent or treat or vomiting and nausea in patients receiving radiation therapy or chemotherapy for cancer treatment and in surgery or postoperative related nausea.
But for many years, GlaxoSmithKline, without the approval of the FDA, quietly promoted the use of Zofran by pregnant women through its drug reps. GSK pushed many doctors to prescribe Zofran for the off-label use of treating the side effects of morning sickness that most women experience during the 1st trimester of pregnancy.
The FDA has assigned Ondansetron, the generic name of Zofran, to “Pregnancy Category B”. This means that animal studies failed to show a risk to the developing fetus and there were no well controlled and adequate studies in pregnant women when it was approved for cancer patients. The Zofran pregnancy category was based on a review of not more than two hundred births. Recent Zofran pregnancy scientific studies of more than 100,000 births demonstrate that it may actually cause fetal harm.
Zofran lawsuit For Birth Defects
In 2012, GlaxoSmithKline plead guilty to criminal charges of withholding safety data from United States regulators and illegally marketing several drugs, including Zofran, and paid $3 billion to the U.S. government as part of the legal settlement.
Court documents show that GSK knew in 1992 that Zofran presented an unreasonable risk of harm to unborn babies because of the drug’s ability to pass through the placenta. In spite of the fact that GSK had this knowledge, the pharmaceutical company continued to market Zofran to pregnant women. GlaxoSmithKline is now going back to court to defend against more specific allegations about birth defects caused by Zofran.
The lawsuits assert several claims against GlaxoSmithKline (GSK). Among them:
- That GSK had a duty to make sure that Zofran was safe before offering it to the general public and that they did not determine its safety risks before selling it.
- That GSK failed to warn the general public about the dangerous side effects of Zofran.
- That GSK advertised Zofran as a safe treatment for hyperemesis gravidarum and morning sickness in spite of the fact that it wasn’t approved for this use.
- That GSK misrepresented that the animal studies demonstrated that Zofran was safe, when in actuality the results showed signs of toxicity and abnormal bone growth.
- That GSK failed to carefully evaluate all the safety information and data on Zofran for use by pregnant women.
- That GSK produced a drug that’s defective.
- That GSK fraudulently and falsely claimed that Zofran was safe for pregnant mothers.
Several recent scientific studies have shown that the use of Zofran by pregnant women may be linked to an increased risk of unborn babies developing birth defects. A 2012 report published by the CDC (Centers for Disease Control) indicated that mothers who took Zofran were at a higher risk of giving birth to babies with craniofacial defects. The report stated that children who were exposed to Zofran during the 1st trimester of pregnancy were two times as likely to develop cleft palates. A 2013 medical report also indicated that the use of Zofran may cause a 34% increase in the overall risk of a baby developing any birth defect and a 100% increase in the risk of congenital heart defects.
In 2014, a Toronto Star investigation found similar risks of birth defects when reviewing medical records of Canadian women who submitted reports to the FDA’s Adverse Events Report Database. The Toronto Star investigation found twenty cases where pregnant women were treated for morning sickness with Zofran and gave birth to children with various birth defects, such as cleft palate, musculoskeletal defects, cleft lip and kidney defects. Additionally, the investigation found reports of two infant deaths after exposure to Zofran.
Zofran Birth Defect Lawyer
If your child was born with a birth defect that may be related to the use of Zofran, you and your baby could be entitled to compensation from GSK. The potential compensation varies depending on the facts of your case. But you can be certain that, if we represent you, we won’t stop until we have pursued the maximum compensation that’s possible under the law.
You have faced a great burden that most likely harmed you and your family emotionally, financially and physically, and that isn’t right. If you are interested in getting the best Zofran birth defect lawyer to represent you, please contact us soon as possible.