Uloric Given New Black Box Warning
February 21, 2019 – The U.S. FDA has added a new black box warning and limited the indication for gout medication Uloric® (febuxostat), which is manufactured by Takeda Pharmaceuticals. In a safety clinical trial, patients who received Uloric had a higher incidence of death compared to patients taking an alternative gout medication, allopurinol.
Under the newly limited indication, Uloric is no longer designated as a first-line treatment for gout. Patients should only be prescribed Uloric if allopurinol has proved ineffective or produced severe side effects. Uloric will carry a black box warning as a result of the safety trial, and will also receive a new Medication Guide, which must be dispensed with the medication at each fill.
Uloric originally received FDA approval in 2009. At that time, the FDA required a Warning and Precaution on the drug label that indicated the potential for cardiovascular events in patients who received the drug. Takeda was also required to conduct a large post-market safety clinical trial. During the trial, five deaths from heart-related causes were observed for every 1,000 patients who received Uloric for a year, compared to 11 per 1,000 patients treated with allopurinol. The trial also found that there were 26 deaths from any cause per 1,000 patients in the Uloric group, compared to 22 deaths per 1,000 for patients taking allopurinol.
The FDA advises patients to speak to their healthcare providers about the benefits and risks of treatment with Uloric. Patients should not stop treatment with Uloric before consulting with their healthcare provider due to the risk of worsening disease. Healthcare providers should discuss with patients who take Uloric a list of signs and symptoms that may indicate a need for immediate medical attention.