Defective Drugs Cases... Novantrone Related Side Affects....
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The drug Novantrone, used to treat multiple sclerosis (MS), causes a significant increase in the risk of a heart condition that impairs the heart's pumping power and seems to raise the risk of congestive heart failure, but to a lesser extent.
Novanrone is one is the fourth drug approved to treat MS in the US. It was approved in 2000 by the Food and Drug Administration soley on the basis of studies conducted only in Europe, not the US.
But one of the FDA's concerns was that Novantrone, mitoxantrone, which was already approved for use as a cancer treatment, might increase the risk of certain side effects. The FDA requested that the company make a commitment to monitor the safety of the drug in the US.
In a review published in the September 24th issue of the journal Neurology, the author states 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.
Other Names:
Mitoxantrone
Adverse Effects/
Potential Injuries:
Congestive Heart Failure
Heart Disease
Left Ventricular Ejection Fraction
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