Anzemet (dolasetron mesylate): Contraindication

Oncology and Cardiology healthcare personnel are informed by the FDA that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting related to cancer chemotherapy because the risk of developing abnormal heart rhythm exists.

Background of Anzemet

Cardiovascular safety concerns have already been noted by the FDA suggesting that Anzemet could cause QT prolongation. A thorough QT study in adults was recommended to be conducted by the drug sponsor for the determination of the prolongation degree.

FDA Alert on Anzemet

New study results indicate that the injection form of Anzemet (dolasetron mesylate) can increase the risk of developing an abnormal heart rhythm, torsade de pointes, which occasionally can be fatal. Patients with heart rate or rhythm problems are at greater risk.

A dose-dependant prolongation in the QT, PR, and QRS intervals on an electrocardiogram is caused by Anzemet.

Recommendation on Anzemet

 “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, patients with bradycardia, patients with 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.

See the DSC for additional recommendations for healthcare professionals and for patients.”

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.