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By Anonymous

The U.S. Food and Drug Administration (FDA) announced that it has changed the labeling of Novantrone (mitoxantrone) to include a boxed warning. This warning is about the potential risk of heart damage and of a form of leukemia called secondary acute myelogenous leukemia, or AML.

The FDA approved Novantrone in 2000 for secondary-progressive, progressive-relapsing, and worsening relapsingremitting MS. Novantrone is a powerful immunesuppressor, which has been shown to significantly delay and reduce relapses in people with these forms of MS. It also slightly slows down the progression of disability, and reduces the number of new, active MS lesions as seen on MRI.

Heart risk

Because Novantrone's potential to damage the heart was known, the FDA allowed only people with normal cardiac function to take the drug and placed a limit on lifetime dose-how much a person could take over time. Since the approval in 2000, studies have shown that impaired cardiac function can occur even early in the treatment. The risk increases with each dose. The FDA is now requiring every person taking Novantrone to be tested for cardiac function before each dose.

Leukemia risk

Secondary acute myelogenous leukemia (AML), a type of cancer, has been reported in a small percentage of people taking Novantrone. In one group, two out of 802 people taking Novantrone developed AML. This represents an elevated risk of .25%. The risk of AML is also increased in people who have been treated with anthracycline drugs.

People with questions about Novantrone should consult a qualified physician.

Copyright National Multiple Sclerosis Society Oct/Nov 2005

Source: Inside MS

http://www.rednova.com/news/health/272950/fda_changes_novantrone_labeling/index.html?source=r_health