Safety Alerts & Recalls
What does this mean?
Most people currently taking Anzemet are taking the tablet form which has a lower risk of of causing abnormal heart rhythms than the risk seen with the injection form. The benefits of preventing the severe nausea and vomiting of chemotherapy or surgery will outweigh the risks of side effects for more people. However, be aware that abnormal heart rhythms are a possible side effect of Anzemet and seek immediate medical care if you experience symptoms of an abnormal heart rate or rhythm, such as a racing heart beat, shortness of breath, dizziness, or fainting while taking this medicine.
Do not stop taking Anzemet without talking to your healthcare professional. If you have any concerns about Anzemet, please review them with your healthcare professional. If you have a history of a heart condition, you may also wish to review this with the healthcare professional who is managing your treatment with Anzemet so they can adjust your treatment if needed.
FDA Publishes Drug Safety Communication: Abnormal Heart Rhythms Associated With Use of Anzemet (Dolasetron Mesylate)
The U.S. Food and Drug Administration (FDA) is warning patients and healthcare professionals about safety concerns with Anzemet (dolesetron mesylate), a medication used to treat nausea and vomiting caused by cancer chemotherapy and general anesthesia used in surgery. The injection form of Anzemet should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients because new data show that the injection form of Anzemet can increase the risk of developing an abnormal heart rhythm called torsade de pointes. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems.
Anzemet injection and tablets continue to be available for prescribing in several other situations. Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting (PONV) that often occurs after surgery. 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 nausea and vomiting caused by cancer chemotherapy (CINV) because the risk of developing an abnormal heart rhythm with the oral tablet form of this drug is less than that seen with the injection form.
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