FDA Approves First Drug for Treating Overdose of Cancer Treatment
US regulators have given a green signal to the first and the only drug that can treat the overdose of chemotherapy or severe allergic reactions. The approval was based on clinical data that showed that overall survival rate of patients with 5-fluorouracil (5-FU) toxicity who received a single dose of Vistogard was 96%.
Vistogard, marketed by Wellstat Therapeutics Corporation based in Gaithersburg, Maryland, if taken orally can block cell damage and cell death caused by fluorouracil chemotherapy.
Fluorouracil and capecitabine (taken orally) are chemotherapy used since decades to treat several types of cancer, including breast and gastrointestinal cancers. Researchers said usually an overdose of fluorouracil or capecitabine is rare, but when it occurs, the effects are serious and can even be fatal.
The patient’s health care provider will determine when he or she can return to their prescribed chemotherapy after they have been treated with Vistogard.
The FDA said in a statement that the Vistogard is not recommended for treating non-emergency adverse reactions that are linked with flourouracil or capecitabine because Vistogard may lower the efficacy of these drugs.
The clinical data showed that patients that were given single course Vistogard i.e. 10g given orally every six hours for a total of 20 doses had 96% survival rate as compared to 16% in historical cases that use standard supportive care measures.
The clinical data also showed that out of total patients treated for overdose 97% were alive after 30 days. On the other hand, in patients who were treated for toxicities, 89% were alive after 30 days.
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