Dangerous Drugs - Novantrone

Novantrone is a drug used in the treatment of certain cancers, including metastic breast cancer, non-Hodgkin's lymphoma, and acute myeloid leukemia.  Novantrone is also used to treat multiple sclerosis (MS) and is one of four drugs authorized to treat the disease in the U.S. Novantrone was approved for use in 2000 by the FDA on the basis of studies conducted abroad, outside the U.S.

Though Novantrone was approved for use as a cancer treatment before it was allowed to be prescribed to sufferers of multiple sclerosis, the FDA was already concerned about its side effects. The regulatory body requested the manufacturer make a commitment to monitoring the safety of the drug in the U.S. In a published review, the author cites several cases in which cardiac complications, including heart failure, resulted after the use of mitoxantrone-based drugs such as Novantrone. Novatrone dramatically increases the risk of developing cardiomyopathy, or the deterioration of the actual heart muscle, which can cause arrhythmia and sudden cardiac death.

In March 2005, Novantrone's label was updated to include a boxed warning informing doctors and patients using Novantrone to employ cardiac monitoring over the course of its use.

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