FDA Safety Alert regarding medications

The U.S. Food and Drug Administration (FDA) recently informed healthcare professionals and the public that preliminary results from a recently completed clinical ...

January 11, 2013

The U.S. Food and Drug Administration (FDA) recently informed healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could predispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.   

FDA will evaluate the final study results when available, and will work with GlaxoSmithKline to explore an alternative single dose regimen that is both safe and effective for the prevention of chemotherapy-induced nausea and vomiting. 

The new information on QT prolongation does not change any of the recommended oral dosing regimens for ondansetron.  It also does not change the recommended lower dose intravenous dosing of ondansetron to prevent post-operative nausea and vomiting.

Ondansetron (Zofran) is already included on the Drugs to Avoid List for people diagnosed with Long QT Syndrome. See the following link: http://qtdrugs.org/

Click here for more information from the FDA regarding this issue.