Safety Communication Issued for Uloric
November 15, 2017 – The U.S. FDA has issued a Safety Communication for Uloric (febuxostat), manufactured by Takeda, and indicated to treat gout. Preliminary results from a post-marketing clinical trial indicate that Uloric may raise the risk of death from cardiovascular events, such as heart attacks or strokes, when compared to another gout treatment, allopurinol.
Based on the results of clinical trials conducted before the FDA approved Uloric in 2009, the drug already carries a Warning and Precaution on its labeling that indicates patients taking Uloric in those trials experienced a higher rate of cardiovascular events compared to those taking allopurinol. The more recent post-marketing clinical trial was conducted to further evaluate the safety of Uloric, as a requirement of the original FDA approval.
The FDA has advised that patients should discuss any questions or concerns they may have about Uloric with a healthcare professional. Patients should not stop taking their medication without first speaking to their doctor. Both patients and healthcare professionals have been urged to report side effects that may be associated with Uloric to the FDA MedWatch program. The FDA has stated that it will continue its evaluation of potential safety concerns involving Uloric, and provide updates as they become available.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.