A common question we address in the Poison Center is if QT interval prolongation is a concern when ondansterone is administered. A 2012 safety announcement by the FDA warned healthcare professionals that administration of ondansterone could cause QT prolongation and potentially Torsades de Pointes (TdP). This announcement was based on preliminary results from a clinical study regarding an intravenous 32mg single dose of ondansterone. The FDA announcement stated, “The lower dose intravenous regimen of 0.15 mg/kg every 4 hours for three doses may be used in adults with chemotherapy-induced nausea and vomiting. However, no single intravenous dose of ondansterone should exceed 16 mg due to the risk of QT prolongation.” The announcement also stated, “the new information does not change any of the recommended oral dosing regimens for ondansterone, including the single oral dose of 24 mg for chemotherapy induced nausea and vomiting.”
Oral ondansterone should not prolong the QT interval. High dose IV ondansterone is the only scenario that increases risk for QT prolongation and TdP. If you have any questions / concerns, contact the Tennessee Poison Center!
Prepared by: Diana Hakim, Lipscomb University College of Pharmacy, PharmD Candidate 2020: Nena Bowman, PharmD, DABAT, Managing Director of TPC.
As with many drugs, the intravenous administration (which bypasses hepatic metabolism and causes higher serum drug concentrations) can cause different effects compared to oral administration. When FDA warnings are released, methods of administration are sometimes overlooked, and the assumption is that any administration can cause the effect discussed in the warning. BTW, remember that the FDA is a committee-a consensus committee. -ds
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Donna Seger, MD
Tennessee Poison Center
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