GlaxoSmithKline and Zofran

Zofran is an antiemetic drug used to treat nausea and vomiting in chemotherapy patients. It was first developed by GlaxoSmithKline in the late 1980s and approved by the FDA in 1991 for treatment. The drug was initially used intravenously, later by injection, and finally released in pill form. In 2007, a generic version of the drug was approved by the FDA. After release, Zofran was ranked as the 20th highest selling brand name drug in the United States. In its first year in pill form, sales figures reached nearly $1.3 billion. Unfortunately, it is unknown how many of these sales were from off-label (unapproved) use.

Zofran became one of the most popularly prescribed drugs for pregnant women suffering from nausea and vomiting during pregnancy. However, Zofran was never approved by the FDA for this use, and a 2013 Zofran study found that the off-label prescription of the drug has resulted in many serious side effects. The FDA had only approved the drug strictly for use in patients undergoing cancer treatment, or for patients who had undergone surgery and were experiencing postoperative nausea. The fact that GlaxoSmithKline never applied for nor received FDA approval for use in pregnant women has resulted in multiple Zofran lawsuits against the pharmaceutical giant.

Some court documents suggest that GSK knew the drug’s risk in causing harm to pregnant women as early as 1992, but the drug continued to be marketed to pregnant women suffering from morning sickness. It is indicated that the drug passes through the human placenta, and it is not know whether or not the drug can be passed through breast milk. Additional studies have found that the way the drug works, in addition to being linked to birth defects, also causes direct symptoms in the mother.

What does Zofran Do?

Zofran works by blocking serotonin receptors in the brain, which lessens feeling of nausea and the urge to vomit. However, a disruption in serotonin levels is potentially harmful in people who have electrolyte imbalances. Pregnant women who have been suffering from morning sickness and vomiting generally have existing electrolyte imbalances. The combination of a disruption in serotonin production coupled with an electrolyte imbalance can result in a variety of side effects, like Serotonin Syndrome, which may lead to changes in behavior and cognitive functions. In extreme cases, it can cause coma and death. Additionally, there it has been suggested that there is a higher risk of birth defects for the newborn if a woman was taking Zofran during pregnancy, which include cleft lip, cleft palate, heart defects, spina bifida, and much more.

GlaxoSmithKline Lawsuit

In 2012, GSK pled guilty in a $3 billion lawsuit to promoting Zofran for off-label use in pregnant women with morning sickness and for paying doctors to prescribe the drug. Six months later, a report published by the CDC indicated that Zofran, when taken during the first trimester of pregnancy, doubles the risk for the cleft palate birth defect. Since then, ongoing studies have uncovered that the drug also increases the risk for congenital heart defects. Since 2012, multiple lawsuits have been filed against GSK for the following claims:

• GSK failed to determine safety risks before selling and marketing the drug to the public.
• GSK failed to warn the public about the known dangerous side effects.
• GSK advertise the drug as a safe drug for morning sickness when the drug was not approved for such use.
• GSK misrepresented animal studies that portrayed the drug as safe; in actuality, trials showed abnormal bone growths and toxicity as a result of the drug.
• GSK failed to evaluate data and safety information pertaining to Zofran’s use in pregnant women.
• GSK produced a defective drug.
• GSK fraudulently claimed that the drug was safe to use for pregnant women.

If you have been prescribed Zofran while pregnant and have suffered any side effects, or given birth to a child with birth defects, contact the law offices of Knapp & Roberts. A Zofran lawsuit lawyer at the firm has over 20 years of experience in handling personal injury claims, and we specialize in dangerous drugs. At Knapp & Roberts, we have dedicated the time and resources need to win lawsuits against large-scale corporations, including pharmaceutical companies. We fight tirelessly to get you the compensation you deserve. We do not collect payment unless you win your case.