Friday, December 17, 2010 (Last Updated: 12/20/2010)
FRIDAY, Dec. 17 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals of a contraindication being added to the prescribing information of dolasetron mesylate (Anzemet), warning that the injection should no longer be used to prevent nausea and vomiting associated with treatment in pediatric or adult patients undergoing cancer chemotherapy.
The contraindication was added to the dolasetron mesylate prescribing label, as the injection can elevate the risk of developing torsade de pointes, an abnormal heart rhythm, which in some cases can be fatal, with the highest risk among those with an underlying heart condition or heart rate or rhythm problems.
On an electrocardiogram, dolasetron mesylate causes a dose-dependent prolongation in the QT, PR, and QRS intervals. While the FDA previously noted a concern with QT prolongation associated with dolasetron mesylate, previous studies did not demonstrate the degree to which the injection could cause this side effect. The FDA recommends that dolasetron mesylate should not be used in patients with congenital long-QT syndrome, and hypokalemia and hypomagnesemia should be addressed prior to administering the drug. The drug may still be used for the prevention and treatment of postoperative nausea and vomiting, as the lower doses used for this indication are less likely to result in arrhythmias.
According the FDA, "Anzemet tablets may still be used to prevent nausea and vomiting associated with cancer 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. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label."
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