Dolasetron, injection to prevent nausea in chemo counter indicates increased risk for heart failure, the FDA warns. Dolasetron should not be used in high doses. Article updated June 8, 2011
December 20, 2010: Source: FDA press release and Medscape
Dolesatron (trade name Anzemet) is a tool that is widely used to prevent nausea and vomiting in chemotherapy to combat. Dolasetron is given by injection. Now, the FDA issued a warning to make this plea to heart failure caused many patients. This emerges from a randomized study. On the FDA website, the official warning: http://www.fda.gov/Drugs/DrugSafety/ucm237081.htm in a PDF ( click here for this PDF document ) gives the FDA guidelines to doctors and nurses how to deal with injections Dolesatron - Anzemet.
Summary of FDA website:
Additional Information for Patients
- Do not Stop Taking Anzemet without talking to your healthcare professional.
- Discuss Any questions or concerns about Anzemet with your healthcare professional.
- Seek immediate care if you experience an abnormal heart rate or rhythm, or Symptoms Such As a racing heart beat, shortness of breath, dizziness, or Fainting while takingcare Anzemet.
- Report Any side effects you experience to the FDA's MedWatch Program Using the information in the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
- Torsades de pointes, an abnormal heart rhythm, Has Been Reported in some patiënten receiving Anzemet injection.
- Anzemet Should not be Used in patient 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 patient with congestive heart failure, bradycardia with patiënten, patiënten with Underlying heart disease, the elderly and in patient who are renally impaired who are takingcare Anzemet.
- No dosage adjustment is Necessary for renal-impaired patient, hepatic-impaired patient, 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 patiënten takingcare Anzemet.
- Advise Patients to contact a healthcare professional if Immediately They experience signs and symptoms or an abnormal heart rate or rhythm while takingcare Anzemet.
- Report adverse events to the involvement Anzemet FDA MedWatch program, Using the information in the "Contact Us" box at the bottom of the page.
Medscape writes about this:
December 1917, 2010 - dolasetron mesylate (Anzemet, Aventis Pharmaceuticals) Should no longer be Used for the prevention of chemotherapy-induced nausea and vomit Because of an Increased risk for cardiac arrhythmias, the U.S. Food and Drug Administration (FDA) Announced today.
New data from a manufacturer Study Requested by the FDA Demonstrate That dolasetron injection can-Increase the Risk for Potentially Fatal torsade de pointes and Has Been linked to a dose-dependent prolongation of the QT, PR, and QRS intervals on electrocardiogram.
"The FDA noted cardiovascular safety concerns Previously Suggested [dolasetron] Which could-cause QT prolongation, can-Which Lead to a Serious and Sometimes Fatal heart rhythm called torsade de pointes," According To date the summary Accompanying the FDA safety announcement.
A randomized, placebo-controlled, crossover trial was Conducted in 80 healthy adults and found thats the difference in QT interval (corrected by Using Fridericia's formula) compared with placebo was 14.1 ms and 36.6 ms for the 100-mg and 300-mg doses or dolasetron, respectively. Prolongation of the PR and QRS interval was noted in patient receiving dolasetron Also in The Same Study on Day 4.
"Based on exposure-response analysis, QT, QRS, and PR interval prolongations Appear to be associated with higher or Concentrations Anzemet's active metabolite, hydrodolasetron," the FDA concludes. Click here to see the whole article in Medscape continue reading.
