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FDA adds contraindication to dolasetron mesylate injection
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The FDA has added a contraindication to the prescribing information for dolasetron mesylate injection. The drug has been associated with an increased risk for abnormal heart rhythm and should no longer be used in pediatric or adult patients to prevent chemotherapy-associated nausea or vomiting.
New data demonstrate that dolasetron mesylate (Anzemet, Sanofi-aventis) is linked with an increased risk for torsade de pointes — an abnormal heart rhythm — which can be fatal in some cases. Patients with underlying heart conditions or those with pre-existing heart rate or rhythm problems are particularly at risk, according to an FDA press release. The drug is also known to cause a dose-dependent prolongation in the QT, PR and QRS intervals on an electrocardiogram.
The FDA recommends that dolasetron mesylate injection not be used in patients with congenital long-QT syndrome. In addition, hypokalemia and hypomagnesemia should be corrected before administering this drug, and should be closely monitored following administration. Patients taking this drug who are elderly or also have congestive heart failure, bradycardia, underlying heart disease or renal impairment should be monitored using electrocardiogram.
Because lower doses of dolasetron mesylate injection are less likely to affect the electrical activity of the heart and result in abnormal rhythms, it can still be used to prevent or treat nausea and vomiting after surgery. In addition, dolasetron mesylate tablets may still be used to prevent chemotherapy-induced nausea or vomiting because the risk for developing abnormal heart rhythm is lower with the oral form of this drug compared with the injection. However, there is a potential risk, which is being added to the “Warning and Precautions” section of the tablet label.
Previous data demonstrated cardiovascular safety concerns associated with dolasetron mesylate injection, but limitations did not clearly show the degree to which the drug caused QT prolongation. According to the press release, the FDA recommended that the drug sponsor conduct a thorough QT study in adults to determine the degree of prolongation.
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