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Posted 14 Dec 2015 by Drugs.com
FRIDAY, Dec. 11, 2015 – Vistogard (uridine triacetate) has been approved by the U.S. Food and Drug Administration to treat an overdose of chemotherapy drugs commonly used to treat cancers of the breast and gastrointestinal tract. The drugs are fluorouracil and capecitabine. An overdose of either drug, while rare, can be life-threatening, the FDA said Friday in a news release. Treatment with Vistogard should begin as soon as possible after the overdose, even if any symptoms of overdose aren't present, the agency warned. The user's doctor should then determine when a return to chemotherapy is appropriate. Vistogard is designed to minimize cell damage caused by chemotherapy. The drug was evaluated in clinical studies involving 135 children and adults who either had taken an overdose of chemotherapy or had developed a life-threatening toxic reaction within 96 hours of being given ... Read more
FDA Approves Vistogard (uridine triacetate) for Emergency Treatment for Overdose of Certain Types of Chemotherapy
Posted 12 Dec 2015 by Drugs.com
December 11, 2015 – The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. “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. While rare, unintentional overdose can occur,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.” Fluorouracil (taken by infusion) and cape ... Read more
Posted 8 Sep 2015 by Drugs.com
September 4, 2015 – Today, the U.S. Food and Drug Administration approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide. Hereditary orotic aciduria is inherited from a recessive gene. The disease is due to a defective or deficient enzyme, which results in the body being unable to normally synthesize uridine, a necessary component of ribonucleic acid (RNA). Signs and symptoms of the disease include blood abnormalities (anemia, decreased white blood cell count, decreased neutrophil count), urinary tract obstruction due to the formation of orotic acid crystals in the urinary tract, failure to thrive, and developmental delays. “Today’s approval and rare pediatric disease priority review voucher underscore the ... Read more