FDA approves first-ever treatment for chemotherapy overdose
Vistogard (uridine triacetate), a product of Wellstat Therapeutics, is indicated for use in patients who have been administered an overdose of fluorouracil, an intravenous chemotherapy drug, or capecitabine, an oral chemo drug. It can also be used for patients who have received the chemotherapy drugs and begin showing signs -- up to four days after treatment -- of severe to possibly fatal toxicities.
Because Vistogard has the potential to reduce the effectiveness of chemotherapy drugs, it is not recommended for treating adverse reactions that are not of an emergent nature.
Both fluorouracil and capecitabine have been prescribed for decades as part of a treatment regimen for breast and gastrointestinal cancer. Overdoses are extremely rare, but they can be deadly.
"Treating cancer requires not only selecting which drug may be most effective and well tolerated, but ensuring the correct dose is given at proper intervals," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. "While rare, unintentional overdose can occur, today’s approval is a first-of-its-kind therapy that can potentially save lives following overdose or life-threatening toxicity from these chemotherapy agents."
Vistogard is an oral medication that works by blocking the damage or death of cells. The drug was tested on 135 cancer patients, both adults and children, in two separate trials. Ninety-seven percent of the patients who overdosed and were treated with Vistogard survived 30 days after the incident; 89 percent of those treated for early-onset toxicity lived 30 days after overdose symptoms developed.
More information about Vistogard can be found online at www.vistogard.com.
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