The U.S. Food and Drug Administration (FDA) has informed that the injection form of Anzemet (dolasetron mesylate) should 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 an abnormal heart rhythm (torsade de pointes), which in some cases can be fatal. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. Anzemet causes a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram (ECG).
Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting (PONV) because the lower doses used for PONV 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. Anzemet tablets may also still be used for prevention of PONV.
Nausea and vomiting are common side effects of chemotherapy and general anesthesia used in surgery. Additional highlights:
- Torsade de pointes, an abnormal heart rhythm, has been reported in some patients receiving Anzemet injection.
- 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 (ECG) monitoring in patients with congestive heart failure, patients with bradycardia, patients with underlying heart disease, the elderly and in patients who are renally impaired who are taking Anzemet.
- No dose adjustment is necessary for renal-impaired patients, hepatic-impaired patients, or the elderly.
- Anzemet also causes dose-dependent PR and QRS prolongation. Drugs known to prolong the PR interval (such as verapamil) or QRS interval (such as flecainide or quinidine) should be avoided in patients taking Anzemet.
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