Nonprofit Urges Removal of Uloric from Market
June 21, 2018 – The nonprofit consumer advocacy group Public Citizen has petitioned the U.S. FDA to remove Takeda’s Uloric® (febuxostat) from the market due to the potential for fatal cardiovascular risks.
Uloric’s 2009 FDA approval is contingent upon further study in the post-market setting. The drug was denied approval in 2005 and 2006. FDA reviewers noted that 9 out of 12 deaths of patients who took Uloric in a clinical trial were attributed to cardiovascular events. The drug is currently approved to provide chronic management of hyperuricemia (an excess of uric acid in the blood) in patients who have gout.
In November of 2017, the FDA released a safety communication regarding possible increased cardiovascular risks with Uloric compared to allopurinol. A study released in March showed that, while cardiovascular risks were similar with Uloric and allopurinol, Uloric was associated with higher rates of all-cause mortality and cardiovascular mortality. According to the study’s lead investigator, “The imbalance in cardiovascular deaths between the two treatments was unexpected and warrants further analyses.”
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
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