Anzemet labeling updated to include warning of arrhythmia

The FDA has notified healthcare professionals that a Contraindication is being added to the labeling for Anzemet injection (dolasetron mesylate, from sanofi-aventis) advising that it no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients. New data demonstrate that Anzemet injection can increase the risk of developing torsades de pointes. Patients at particular risk are those with underlying heart conditions or existing arrhythmias. Anzemet causes a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram.

Anzemet should not be used in patients with congenital long-QT syndrome. Hypokalemia and hypomagnesemia should be corrected before administering Anzemet. These electrolytes should be monitored after administration as clinically indicated. Use electrocardiogram monitoring in patients with congestive heart failure, bradycardia, underlying heart disease, the elderly and in patients who are renally impaired who are taking Anzemet. Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting because the lower doses used are less likely to affect the electrical activity of the heart and result in abnormal heart rhythms.

Anzemet tablets may still be used to prevent CINV because the risk of developing an abnormal heart rhythm with the oral form of this drug is less than that seen with the injection form. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237341.htm.