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 chemotherapy. Of clinical trial participants given Vistogard, 89 percent to 97 percent were still alive after 30 days, the agency said.
Vistogard is not recommended for non-emergency adverse reactions associated with chemotherapy, as the new drug could weaken the effects of chemotherapy, the FDA said. Vistogard’s most common side effects included diarrhea, vomiting and nausea.
Vistogard is marketed by Gaithersburg, Md.-based Wellstat Therapeutics.
The FDA has more about this approval.
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