GlaxoSmithKline (GSK) developed the drug Zofran to treat acute and intense nausea. In 1991, the U.S. Food and Drug Administration (FDA) approved Zofran solely to combat nausea and vomiting related to chemotherapy, radiation, and surgery patients. The FDA approved Zofran’s generic counterpart, ondansetron, in 2006.
Even though the drug was only indicated for use in specific and severe cases related to cancer treatment and surgery, GSK began marketing Zofran “off-label” (not FDA approved) for pregnancy-related nausea, also known as morning sickness. By 2006, Zofran became the most commonly prescribed antiemetic (a drug prescribed to treat vomiting and nausea) in pregnant women.
If you took Zofran while pregnant and your child was born with a disability or defect, call a Kansas City Zofran injury attorney at (816) 253-8606. We can help you explore your legal options.
Zofran Studies & Trials
GSK did not engage in any studies or medical trials to research the effects that Zofran might have on a fetus before marketing it to pregnant women. In 1991, when the FDA first approved Zofran, the only data that GSK submitted regarding the effect of Zofran on babies in utero were two animal experiments done in 1984 and 1985.
These studies were done on rats and rabbits that have gestation periods of approximately one month or less. In these studies, Zofran was not administered until after the first third of gestation was nearly over. Therefore, these experiments could not give any indication of the drug’s effect in early fetal development. The experiments did, however, indicate toxicity, incomplete bone growth, and intrauterine fetal death.
A later study conducted in humans confirmed that ingested Zofran crossed the human placenta barrier and exposed fetuses to substantial concentrations. A 2004 study on ondansetron and fetal development found that the drug did not considerably increase risk for major malformations. It did not examine lesser malformations, lesser risk, or any specific malformation. This study also had a sample size of only 174 pregnancies. For perspective, another antiemetic prescribed to pregnant women is Doxylamine–Pyridoxine (also marketed as Bendectin, Diclegis, and Duchesnay). The fetal safety data for that drug is based on more than 250,000 pregnancies.
Two Key Studies Link Zofran to Birth Defects
- The Centers for Disease Control and Prevention (CDC) found in a 2011 study with a sample size of over 4,500 cases that ondansetron taken in the first trimester doubled the risk of cleft palate incidence.
- A 2014 study revealed that babies exposed to Zofran in utero experienced a 30% increase in major malformations due to an increase in heart problems.
FDA Categorizations for Pregnancy Risks
The FDA categorizes drugs based on their risk in pregnancy. The classifications are A-D, which indicate varying degrees of risk, X, which is contraindicated in pregnancy, and N, which is not yet classified. Currently, ondansetron (Zofran) has a B classification, meaning that either animal studies have shown no adverse effect but there are no adequate studies in pregnant women, or animal studies showed an adverse effect on the fetus but human trials have not shown a risk. This classification is due, in part, to the fact that GSK only submitted animal studies to the FDA and no human trials.
GSK did not seek or receive FDA approval to market Zofran to pregnant women. Consequently, the use of Zofran by pregnant women – a drug they believed to be safe – has caused devastating results:
- Cleft palate
- Major kidney defects
- Heart defects
- Musculoskeletal abnormalities
- Decreased birth weight
- Hearing loss
- Vision problems
- Abnormal blood pressure
These birth defects may require extensive surgeries and a lifetime of therapies and treatment.
GSK Pleads Guilty to Off-Label Promotion of Zofran
In 2012, GSK pled guilty to the off-label promotion of its drugs, including Zofran. GSK’s irresponsible and illegal conduct has irreparably damaged families all over the world. Cullan & Cullan specializes in cases like these and can help you with your lawsuit if your baby was born with a birth defect due to Zofran. Our Kansas City Zofran lawyers can advise you of your options and can help you take the right steps to seek justice.
Please contact us today at (816) 253-8606 to discuss your case.