Novantrone (Generic: Mitoxantrone hydrochloride) causes a significant increase in the risk of a heart condition that impairs the heart’s pumping power and may raise the risk of congestive heart failure. Novantrone is used to treat multiple sclerosis (MS). Novantrone is one is the four drugs approved to treat MS in the US. It was approved in 2000 by the Food and Drug Administration solely on the basis of studies conducted only in Europe, not the US.
While Novantrone (mitoxantrone) was already approved for use as a cancer treatment, the FDA was concerned about its side effects. The FDA requested that the manufacturer make a commitment to monitor the safety of the drug in the U.S. In a review published in the journal Neurology, the author stated that several cases of cardiac complications including heart failure have occurred in three mitoxantrone studies. The review covered three studies that included a total of 1,379 MS patients taking mitoxantrone.
In one study, 4 out of 124 patients (3.23%) developed a condition called diminished left ventricular ejection fraction (LVEF), a measure of the heart’s blood-pumping strength. In a second study, about 2% of patients experienced diminished LVEF. The third study did not include LVEF measurements, but 2 of the 452 patients (0.44%) died from congestive heart failure.
Novantrone’s label was updated in March 2005 with a boxed warning to inform doctors and patients that those who receive Novantrone should receive cardiac monitoring before the first dose and every dose of the drug.
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