Home Rx News FDA Issues Advisory Related to Gout Medication — Febuxostat (Uloric)

FDA Issues Advisory Related to Gout Medication — Febuxostat (Uloric)


The FDA on Nov. 15, 2017, issued a public alert advising that the drug febuxostat (Uloric), used by many for treatment of gout may have an increased risk of heart-related death when compared to the use of allopurinol.

While the FDA did not disclose extensive details, the alert presumably relates to a clinical trial conducted by Uloric’s manufacturer, Takeda Pharmaceuticals. The Clinical trial began in April 2010 and was completed on May 15, 2017.  The clinical trial contemplated participation of up to 7,500 individuals with the FDA confirming that more than 6,000 individuals participated in the trial.  Among the purposes of the study was the evaluation of “whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications…. [including] heart attacks, strokes, and angina….”  Details of the study are published at www.clinicaltrials.gov. However, the results of the study are not posted.  According to the FDA report, febuxostat did not increase the risk of  heart attacks, strokes and angina in comparison to allopurinol use.  However, according to the FDA, “when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

Febuxostat was previously approved by the FDA for treatment of gout, a type of arthritis in adults.  The clinical trial was a condition of the FDA approval in 2009 because clinical trials conducted prior to approval also showed a higher rate of heart-related problems with patients treated with febuxostat compared to those treated with allopurinol.  Gout results when the body accumulates excess uric acid leading to sudden attacks of redness, swelling and joint pain.

SLN Sources: FDA Alert; Takeda Clinical Trial.