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Drug & Device News

Chemotherapy Overdose Medication Approved

On Dec. 11, 2015, the U.S. Food and Drug Administration (FDA) approved a new medication for the emergency treatment of overdoses of the cancer treatments fluorouracil or capecitabine, and for the treatment of certain life-threatening toxicities within four days of receiving these cancer treatments. Fluorouracil is taken by infusion and capecitabine is taken orally. Both these types of chemotherapy are used to treat several types of cancer, including breast and gastrointestinal cancers. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, noted that although overdoses of these cancer drugs are rare, they do occur. “Today's approval is a first-of-its-kind therapy,” he said, and it will “potentially save lives following overdose or life-threatening toxicity from these chemotherapy agents.”

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