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The risk information has been added to Bristol Myers' drug label for sprycel, according to Reuters, citing the FDA.
The U.S. agency initially approved the drug for treatment of the rare blood cancer called chronic myeloid leukemia in October 2010. The disease is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.
Sprycel, which is taken orally, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells, allowing bone marrow to begin reproducing normal red and white blood cells.