The US Food and Drug Administration (FDA) has issued a warning against using the injectable form of dolasetron mesylate to prevent nausea and vomiting associated with cancer chemotherapy. New data shows that dolasetron can increase the risk for developing abnormal heart rhythms. The oral tablets of dolasetron may be still be used for this indication; however, a strong warning is being added to the drug’s label.
Patients with congenital QT syndrome or other underlying heart rate or rhythm problems should not receive either form of the drug.
Results from the manufacturer’s QT study, a randomized, placebo- and active-controlled crossover study show a dose-dependent prolongation in the QT, RP, and QRS intervals on electrocardiogram. For the tablet form, this risk was found to be less than that seen with the injectable form.
Read the FDA announcement: