FDA Issues Safety Warning Due to Increased Death Rates From Febuxostat

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In February of 2019, the FDA issued a new black box warning for the medication febuxostat, which users currently take for gout. The warning states that patients who take the drug are at an increased risk of death due to heart related complications.

A recent report showed 15 recent deaths due to heart-related issues for every 1,000 patients who took febuxostat for a year. Further research turned up there were a total of 26 deaths from any cause per 1000 patients who took the drug for a year. “This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” according to an official drug safety communication from the FDA.

The findings were largely the result of a study by CARES (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities), who ran a study of postmarket clinical trials with more than 6,000 gout patients who were treated with febuxostat for at least one year.

“It is important to note that in the CARES study, most patients taking xanthine oxidase inhibitors were on allopurinol versus febuxostat,” said Maha Saad, associate clinical professor at St. John’s University College of Pharmacy and Health Sciences in Queens, NY. She continued, “This could be attributed to the long-term experience with allopurinol and the higher cost with febuxostat.” she stated in a quote to Pharmacy Today.

The FDA also stated that febuxostat should only be used for patients who have either had an adverse reaction to allopurinol or to those for whom allopurinol will not work. 

Gout is a chronic illness affecting over eight million adults in the United States. Febuxostat is used for the treatment of gout since gaining approval in 2009. Since the drugs approval the prescribing information for febuxostat has included a warning about possible cardiovascular events in patients treated with the drug. As of this time, there is a need for more treatments in this area, the agency states.

Since the release of this study, the FDA has released an update in regards to the prescribing information with a boxed warning of increased risk of death as well as stating that the approved usage of this drug should be limited to certain patients for whom other safer methods have not been beneficial.

Darryl Sleep, M.D., Head, U.S. Medical Office, Takeda Pharmaceuticals has issued a response to the findings.

“Patient safety is Takeda’s top priority, and CARES provides physicians with important safety information about Uloric that is useful when evaluating treatment options for patients with hyperuricemia and gout. We are actively working with regulators and medical experts to ensure physicians have comprehensive and accurate information to make educated treatment decisions.” 

Darryl Sleep, M.D., Head, U.S. Medical Office

As of this time, despite the warnings issued by the FDA, febuxostat is approved as a generic medication for the treatment of gout.

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