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The gout medication Uloric (febuxostat) may increase the risk of heart attack, according to recent studies. The FDA recently required manufacturer Takeda Pharmaceuticals place a new black-box warning on the product label to alert doctors and patients to an increased risk of heart-related death and death from all causes.

The FDA also changed the prescribing information for Uloric, limiting its use to patients who tried allopurinol—a leading gout medication for decades—and did not have good results with it. This move, in essence, relegated Uloric to a second-line treatment.

Studies Find that Uloric Increases Risk of Cardiovascular Death

In a 2018 study called the “CARES” trial, researchers followed over 6,000 patients with gout and previously existing cardiovascular disease who were taking either febuxostat or allopurinol for a median of 32 months. They found that all-cause and cardiovascular mortality were higher in the febuxostat group than in the allopurinol group.

The scientists could not explain why febuxostat caused this increased risk, as other studies on the drug showed no toxic effects related to cardiac rhythm, function, or metabolism. They noted that in patients with gout and cardiovascular disease, treatment with febuxostat resulted in “higher all-cause mortality, resulting from an imbalance in cardiovascular deaths…” when compared with allopurinol.

Other studies have found similar results. In one published in February 2019 in the International Journal of Rheumatology, researchers analyzed 10 studies that compared febuxostat to allopurinol. Altogether, these studies involving over 14,000 participants with a median age of 54 years. They found that compared with other gout treatments, febuxostat did not increase or decrease the risk of cardiovascular disease, but could increase the risk of cardiovascular disease-related death.

In another study—the results of which were presented at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in Chicago—researchers looked at 256 gout patients, some of which were treated with allopurinol and some with febuxostat. Sixty-nine of them already had cardiovascular disease.

Results from this study showed that febuxostat was associated with a significant 3.9-fold increased risk of new cardiovascular events (like heart attack and stroke), compared with allopurinol. Among patients with prior cardiovascular disease, febuxostat was associated with a significant 20.8-fold increased risk of new cardiovascular events compared with allopurinol. Over a follow-up period of 9.5 months, some of the patients experienced events like congestive heart failure, coronary heart disease, peripheral artery disease, and stroke. Some patients died.

Patients Should Talk To Their Doctors About Uloric

If you take Uloric for gout, talk to your doctor. Tell him or her if you have a history of heart problems or stroke, and together you can discuss the risks and benefits of continuing to use the medication. Meanwhile, watch for symptoms of a cardiovascular event, including chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking, and sudden severe headache. If you experience these symptoms, get medical help immediately.

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