Dolasetron, injectie om misselijkheid bij chemo tegen te gaan geeft vergroot risico op hartfalen, waarschuwt de FDA. Dolasetron mag niet meer gebruikt worden in hoge dosis. Artikel update 8 juni 2011
20 december 2010: Bron: Medscape en FDA persbericht
Dolesatron (merknaam Anzemet) is een middel dat veelvuldig gebruikt wordt om misselijkheid en braken bij chemokuren tegen te gaan. Dolasetron wordt gegeven met injectie. Nu heeft de FDA een waarschuwing uit doen gaan dat dit middel bij te veel patienten hartfalen veroorzaakt. Dit blijkt uit een gerandomiseerde studie. Op de FDA website staat de officiele waarschuwing: http://www.fda.gov/Drugs/DrugSafety/ucm237081.htm In een PDF (klik hier voor dit PDF document) geeft de FDA richtlijnen aan artsen en verpleegkundigen hoe om te gaan met injecties met Dolesatron - Anzemet.
Samenvatting van 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 taking Anzemet.
- Report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
- 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.
- Advise patients to contact a healthcare professional immediately if they experience signs and symptoms of an abnormal heart rate or rhythm while taking Anzemet.
- Report adverse events involving Anzemet to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.
Medscape schrijft er dit over:
December 17, 2010 — Dolasetron mesylate (Anzemet; Aventis Pharmaceuticals) should no longer be used for the prevention of chemotherapy-induced nausea and vomiting because of an increased risk for cardiac arrhythmias, the US 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 previously noted cardiovascular safety concerns which suggested [dolasetron] could cause QT prolongation, which can lead to a serious and sometimes fatal heart rhythm called torsade de pointes," according to the data summary accompanying the FDA's safety announcement.
A randomized, placebo-controlled, crossover trial was conducted in 80 healthy adults and found that 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 of dolasetron, respectively. Prolongation of the PR and QRS interval was also noted in patients receiving dolasetron in the same study on day 4.
"Based on exposure-response analyses, QT, QRS, and PR interval prolongations appear to be associated with higher concentrations of Anzemet's active metabolite, hydrodolasetron," the FDA concludes. Klik hier om het hele artikel in Medscape verder te lezen.
