Vistogard Approved for Fluorouracil Toxicity
December 14, 2015 – The U.S. Food and Drug Administration (FDA) approved Vistogard (uridine triacetate), manufactured by Wellstat Therapeutics. Vistogard is indicated for the treatment of adults and children who receive an overdose of fluorouracil or its prodrug capecitabine in the treatment of cancer, as well as for patients who develop certain severe or life-threatening toxicities within four days of receiving cancer treatments. Importantly to note is the fact that, Vistogard must not be used for the treatment of non-emergency adverse reactions associated with fluorouracil or capecitabine due to efficacy reasons. Although Vistogard is not yet available in the U.S. market, Wellstat Therapeutics plans to do so as soon as possible.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.