Timeline of Events Leading to Zofran Recall
January 4, 1991: The FDA approved Zofran (ondansetron) for chemotherapy-related nausea and vomiting ( pdf).
January 5, 1993: The New York Times reported that the FDA approved a pill form of Zofran ( pdf).
June 22, 1995: GlaxoWellcome submited a New Drug Application to the FDA for a 4mg/5mL dose of Zofran (ondansetron hydrochloride) ( pdf @ p.10).
June 24, 1997: The FDA approved GlaxoWellcome's New Drug Application (see June 22, 1995, entry).
March 9, 1999: The FDA issued a warning letter ( pdf) to GlaxoWellcome regarding its marketing of anti-nausea drug Zofran.
According to that letter, Glaxo failed to warn consumers about Zofran's adverse side effects while touting its effectiveness with statements such as:
- "Zofran can,"
- "24-hour control," and
- "Prevention of emesis I to 2 days after chemotherapy."
December 27, 2006: The FDA approved generic versions of Zofran ( pdf).
August 2011: To test Zofran's cardiac risks, GlaxoSmithKline began a study titled "A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron, a 5-HT3 Antagonist, on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects ( pdf)."
September 15, 2011: The FDA issued a Drug Safety Communication regarding Zofran ( pdf). That alert stated that:
- Zofran may change the heart's electrical activity and that change could cause an abnormal heart rhythm such as Torsade de Pointes; and
- Zofran's labels would therefore be revised. Per the FDA:
The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Additionally, recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.
The FDA also ordered Zofran maker GlaxoSmithKline to conduct QT prolongation studies.