Van Wey Law is currently investigating Zofran birth defect injury cases in all 50 states. If you or somebody you know has had a baby with a birth defect after taking Zofran during her pregnancy, please contact us toll-free, 24 hours a day at (888) 694-8093, or complete the short form above for a free case consultation and evaluation.
It is alleged that GlaxoSmithKline, the manufacturer of Zofran, concealed their knowledge that the drug could cause serious birth defects.
You may qualify to file a lawsuit against the manufacturer of Zofran if you took the drug during your pregnancy and your baby was born with a cleft palate or a heart defect. Our attorneys are currently helping victims who have gone through this experience and we offer free evaluations to determine if you have a case. The lack of testing and warning from GlaxoSmithKline, the manufacturer, resulted in doctors and patients being unaware of the risks of birth defects caused by taking Zofran. They did not perform the proper human studies on the effects of Zofran in pregnant women, and they were aware of birth defects as a result of taking the drug as early as 1990.
Zofran (ondansetron) is a prescription medication that can be prescribed for women who experience severe nausea and vomiting during their first trimester of pregnancy. Although quite effective, recently studies indicate that it also causes severe adverse reactions in both mother and baby. Zofran, which has been widely marketed as a morning sickness remedy, was first approved by the FDA in 1991 for use in cancer patients as prevention for nausea. It has never been approved for treatment of nausea in pregnant women. Prior to its approval by the FDA, GlaxoSmithKline failed to conduct any research on the effects of the drug on pregnant women.
Zofran Linked to Serious Birth Defects
According to the U.S. Food and Drug Administration (FDA), taking Zofran while pregnant can potentially lead to serious birth defects, but it is still being prescribed to pregnant women who are not aware of the dangers. Because morning sickness occurs most often in the first trimester of a pregnancy, the drug is often ingested at this time, during the most crucial period of fetal development. Despite its potential risks, the FDA has not stopped Zofran from being prescribed.
Reports of Adverse Reactions Concealed
In 1992, GSK began receiving reports of adverse reactions in the form of birth defects associated with Zofran. These reports were never disclosed to pregnant women or their prescribing physicians. The most common types of birth defects that can potentially result from taking Zofran include:
- Musculoskeletal anomalies
- Mouth deformities
- Heart defects
Studies Link Zofran to Birth Defects
There have also been medical studies which have proven a link between an increased risk of a baby being born with birth defects when the mother has taken Zofran:
- In 2011, a study done by the Centers for Disease Control and Prevention (CDC) showed that Zofran doubles the risk of birth defects.
- Another study performed six months later, based on 900,000 births, linked Zofran to a 30% increased risk of birth defects overall, and a doubled risk of heart defects.
- In December of 2014, a study published by Australian researchers linked Zofran taken during pregnancy to a 20% increased risk of birth defects. They also found possible links to certain kidney defects.
- Also in December of 2014, Swedish researchers published a study in Reproductive Toxicology that linked Zofran to a doubled risk of septal heart defects (known more commonly as “hole in the heart” defects). This study was conducted on 1,400 infants exposed to Zofran in the first trimester of pregnancy.
- A Danish study performed on over 600,000 women taking Zofran showed there was no high risk. In the same day, however, another Danish study showed there was a doubled risk for infant heart defects.
- A report published by the Toronto Star in June of 2014 showed at least 20 cases linking Zofran to birth defects. These included two fetal deaths, multiple heart defects, kidney defects, musculoskeletal defects and poor fetal growth.
Fighting for Your Right to Compensation
At Van Wey Law, we feel that pregnant women would not have taken Zofran while pregnant had they known of the risks to their unborn child. GlaxoSmithKline must be held liable for concealing these risks. GSK prioritized profit over public safety, and that is unacceptable. We are proud of our track record of legal achievements, but we also pride ourselves on consistently providing our clients with the individual attention they deserve. We are confident in our ability gain for you the compensation you deserve. We are here to serve you. Contact us today.