During pregnancy, many women struggle to function while performing day to day tasks as a result of debilitating nausea and vomiting, often referred to as extreme morning sickness or hyperemesis gravidarum. Doctors began prescribing Zofran for the treatment of this condition despite the fact that it had only been approved for use by patients suffering from nausea due to chemotherapy treatments. Sadly, some of these women later discovered that their children were born with birth defects likely attributable to the Zofran use.
Important Dates on the Zofran Timeline
How did this tragedy happen? The following is a timeline of events:
- On January 4, 1991, the U.S. Food and Drug Administration approved the use of Zofran for nausea and vomiting caused by chemotherapy.
- On January 5, 1993, the U.S. Food and Drug Administration approved the use of Zofran in pill form.
- On June 22, 1995, GlaxoWellcome submitted a New Drug Application to the FDA. This application pertained to a new dose of Zofran.
- On June 24, 1997, the New Drug Application was approved.
- On March 9, 1999, The FDA issued a warning letter to GlaxoWellcome. The letter alleged that the company had failed to warn consumers about Zofran’s adverse side effects. It also stated that the company made statements in its marketing proclaiming the drug’s effectiveness without mentioning the adverse side effects.
- In the year 2000, GlaxoWellcome and SmithKline Beecham merged to form GlaxoSmithKline.
- On December 27, 2006, the FDA approved the use of generic versions of Zofran.
- In August 2011, GlaxoSmithKline began a study to look into the cardiac risks potentially associated with the use of Zofran.
- On September 15, 2011, the FDA issued a Drug Safety Communication regarding Zofran use. The alert alleged that Zofran use might change the heart’s electrical activity. That change could lead to an abnormal heart rhythm. In addition, the alert stated that Zofran’s labels would be revised to include a warning to avoid the use of the drug by patients with congenital long QT syndrome. The labels would also advise ECG monitoring for patients who use Zofran and also have electrolyte abnormalities, congestive heart failure, Brady arrhythmias, or who are taking other medications that can lead to a condition known as QT prolongation. The company was also ordered to conduct additional studies.
- In January 2012, GlaxoSmithKline completed the study relating to Zofran use and cardiac risks. The study showed that the 32mg dose of Zofran could cause QT interval prolongation. This could then cause a fatal heart rhythm.
- On July 2, 2012, GlaxoSmithKline pleaded guilty to promoting the use of the drug for off-label uses and paying doctors to prescribe the drug. The off-label uses that the company admitted to encouraging the use of Zofran for included morning sickness in pregnant women. In addition, the company agreed to pay a $3 billion settlement. This information was reported in a press release issued by the U.S. Department of Justice.
- On July 5, 2012, the FDA released a podcast relating to the results of the GlaxoSmithKline study of Zofran use and cardiac problems.
- On December 4, 2012, the FDA issued a Drug Safety Communication. The brand name and generic versions of Zofran in the 32 mg dose were recalled.
- In January 2012, a report was published alleging that taking Zofran during the first trimester of pregnancy doubles the risk of a cleft palate birth defect. The report was prepared by the Center for Disease Control’s National Center on Birth Defects and Developmental Disabilities.
- In June 2012, GlaxoSmithKline pleaded guilty to federal criminal health care fraud charges. The company was charged with violating the Food, Drug, and Cosmetic Act with regard to three of its drugs, including Zofran. The company agreed to pay $1 billion in criminal penalties and an additional $2 billion in civil penalties for wrongfully promoting Zofran for off-label use and for paying kickbacks to doctors to prescribe the drug for such off-label uses. Again, one of the off-label uses the drug was illegally promoted for included the treatment of morning sickness in pregnant women.
- In August 2013, a study reveals an increased risk of congenital heart defects in children born to mothers who used Zofran during their first trimester of pregnancy.
- In July 2014, researchers confirm that Zofran crosses the placenta during pregnancy.
Today, far too many women are dealing with the harmful effects caused by use of the drug during their pregnancies. If your child was born with a birth defect that you believe was caused by Zofran use, we can help protect your legal rights. We encourage you to check out our many case results to learn more about how we have helped other clients pursue legal action after suffering harm caused by a defective drug.