Novantrone (mitoxantrone) is an anti-cancer drug that was approved by the Food and Drug Administration ("FDA") in October 2000 for the treatment of several forms of advanced Multiple Sclerosis ("MS"). Since MS is a disease that attacks the nervous system by destroying the myelin sheath, or insulation, surrounding neurons, Novantrone acts to suppress the activity of cells that are thought to cause this condition. The approval by the FDA however, was based solely on limited studies performed in Europe and not in the United States.

Based on findings from these studies, the FDA approved Novantrone for reducing neurologic disability and/or the frequency of clinical relapses in:

1. patients with secondary progressive MS (disease that has changed from relapsing-remitting to progressive at a variable rate)

2. progressive-relapsing MS (disease characterized by gradual increase in disability from onset with clear, acute relapses along the way);

3. worsening relapsing-remitting MS (disease characterized by clinical attacks without complete remission, resulting in a step-wise worsening of disability.

Novantrone was not however, approved for the treatment of primary-progressive MS (characterized by progression from disease onset with no acute attacks or remissions).

While the FDA, in the opinion of many, acted too quickly to allow the marketing of Novantrone for the treatment of MS, the agency was well aware that the drug might increase the risk of certain side effects. Accordingly, the FDA required a commitment from the drug's manufacturer to monitor it's safety record in the United States. As indicated by studies performed since the approval of this drug, Novantrone is a potentially deadly medication.

In a review published in the September 24th issue of the journal Neurology, several cases of cardiac complications including heart failure were documented to have occurred in three mitoxantrone studies. The review covered 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 has been clearly shown to cause a significant increase in the risk of a heart condition that impairs the heart's pumping power and raises the risk of congestive heart failure. The risk of heart disease has further been shown to increase with cumulative doses, and patients with MS should not receive more than 8 to 12 doses administered over a two to three year period. Because the potential side effects of this drug are so severe, the professional labeling recommends that doctors closely monitor their patients by performing regular testing of the heart and blood. Patients who are not monitored may face the need for heart transplants or ultimately, face certain death.

Furthermore, in January 2003, the product label was changed to read: "Secondary acute myelogenous leukemia (AML) has been reported in cancer patients treated with anthracyclines. NOVANTRONE is an anthracenedione, a related drug. Secondary AML has also been reported in cancer patients and multiple sclerosis patients who have been treated with NOVANTRONE."