In 1991, the FDA approved Zofran, an antiemetic medication manufactured by GlaxoSmithKline (GSK) to prevent nausea and vomiting caused by cancer chemo therapy, radiation therapy, and surgery. Zofran has never been approved by the FDA for any other use. Zofran works by blocking serotonin receptors in the brain, which would otherwise generate a reaction causing a patient to succumb to nausea and vomiting.
Uses for Zofran
Studies have shown that as many as 80 out of every 100 pregnant women experience nausea and vomiting during the first trimester of pregnancy. Although Zofran was approved for distribution only for chemotherapy and radiation patients, GSK promoted the drug as an effective means to fight the same symptoms in pregnant women. Doctors now regularly prescribe Zofran to expectant mothers suffering from morning sickness. Zofran is prescribed to approximately 1 million women per year.
GSK labeled Zofran under a category which specified that there was no evidence of risk to humans, but because GSK could not demonstrate that the drug was safe, it was never given FDA approval for distribution to pregnant women. In fact, GSK had evidence to the contrary. Its own animal studies confirmed that the medication crossed the placental barrier. Now, epidemiological studies demonstrate that Zofran can be linked to congenital birth defects in children whose mothers took the drug. Such birth defects include heart conditions, cleft palate, cranial deformities and CTEV (or Club foot).
GSK has come under fire for deliberately misleading the public in claims that Zofran is a safe medication. In 2012, the Department of Justice brought claims against GSK for its fraudulent and illegal off-label promotion of drugs, including Zofran. GSK ultimately agreed to pay $3 billion to settle the claims. GSK is now being pursued in civil actions for this misconduct.
GSK now finds itself at the center of new lawsuits regarding its liability for the damaging side effects of Zofran. A few of the claims are as follows:
- GSK had a responsibility to properly determine the drug’s safety before offering it on the market, and failed to do so.
- The company negligently failed to advise the public about dangerous side effects, despite evidence that GSK knew of an unreasonable danger to prenatal infants as early as 1992.
- GSK targeted pregnant women in advertising and marketing campaigns despite the fact that the drug was not FDA approved for use against morning sickness.
- All data and information regarding the safety of Zofran was not adequately assessed before releasing the drug to market.
- The company provided misinformation concerning animal studies alleging that Zofran was safe, when in reality the side effects showed damage to bone formation.
How can this information affect consumers?
Women who believe that they may have taken Zofran, or were prescribed a similar generic form of the drug, should seek medical and legal counsel. If the use of Zofran may have resulted in congenital birth defects, those affected may be eligible to partake in legal action against GSK in order to recover damages or receive compensation for medical expenses.