Anzemet Injection Can Cause Potentially Fatal Heart Rhythm Problem, FDA Warns

<"">Anzemet (dolasetron mesylate) injection should no longer be used to prevent chemotherapy-induced nausea and vomiting in children or adults, according to a warning from the US Food & Drug Administration (FDA). Using Anzemet in this manner has been associated with a potentially fatal heart rhythm problem called Torsade de pointes, the agency said. A contraindication for Anzemet injection stating that it should not be used to prevent nausea and vomiting associated with cancer chemotherapy treatment is being added to the drug’s label.

Anzemet is manufactured by Sanofi-Aventis and was approved by the FDA in 1997 for the treatment of nausea. The prescription drug is available in both oral tablets and through intravenous injections. Previous clinical trials and studies have shown that there were cardiovascular safety concerns with Anzemet, and the drug contained a warning for cardiovascular events.

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, the FDA said. Anzemet tablets may also still be used to prevent nausea and vomiting in patients undergoing chemotherapy 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, according to the FDA. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label.

According to the FDA warning, new data from a manufacturer study demonstrate that Anzemet injection can increase the risk of developing Torsade de pointes, an abnormal heart rhythm, 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.

Torsade de pointes, a French term that literally means “twisting of the points,” is a lethal form of ventricular tachycardia. Without treatment, few patients survive Torsade de pointes once it develops. Patients should seek immediate care if they experience an abnormal heart rate or rhythm, or symptoms such as a racing heart beat, shortness of breath, dizziness, or fainting while taking Anzemet, the FDA said.

According to the FDA, Anzemet should not be used in patients with congenital long-QT syndrome. Hypokalemia (low potassium levels) and hypomagnesemia (low magnesium levels) should be corrected before administering Anzemet. These electrolytes should be monitored after administration as clinically indicated. The FDA is also advising that doctors 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.

The FDA said patients should:

• Not stop taking Anzemet without talking to their healthcare professional.

• Discuss any questions or concerns about Anzemet with their healthcare professional.

• Seek immediate care if they experience an abnormal heart rate or rhythm, or symptoms such as a racing heart beat, shortness of breath, dizziness, or fainting while taking Anzemet.

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