A large study shows that there is a strong relationship between Uloric and heart disease, meaning that treatment with the gout drug may be dangerous.
Gout is an arthritic condition which involves the buildup of uric acid, often in the small joints of the fingers and toes.
Uric acid is a natural byproduct of cellular processes, but people with gout are unable to sufficiently process it out of the body.
Excess uric acid can form needle-like crystals in the joints which can cause symptoms including severe inflammation, intense joint pain, lingering discomfort, inflammation, redness, and limited range of motion. Dangers of Uloric and heart disease might not be known by all users.
Many individuals are able to manage their condition through lifestyle and dietary changes. However, some patients require more intensive treatment of their arthritic condition and may be prescribed medication for treatment. One drug available for treatment of gout is Uloric.
Uloric, which was approved for use in 2009, was developed by Takeda Pharmaceutical and was designed to be a safer alternative to allopurinol.
Allopurinol has been around for decades and has commonly been prescribed as a gout treatment, but is associated with severe allergic reactions and kidney problems.
Although Uloric was designed to not carry these risks, the results of the CARES trial showed that Uloric and heart disease may be linked.
In March 2018, the shocking results of the CARES trial were released at the American College of Cardiology’s 67th Annual Scientific Session. The results were later published in the New England Journal of Medicine by the lead researcher on the trial, William B. White.
According to White, the results of the CARES trial were “entirely unexpected” after it was shown that Uloric and heart disease and related. The CARES trial compared the outcomes of 6,000 patients taking either Uloric or allopurinol.
Although Uloric and allopurinol were comparable in the treatment of gout, researchers were surprised when results showed that Uloric patients experienced a higher risk of death related to heart disease.
“The results were consistent across many subgroups; there was no evidence of a relationship with age, gender, race or ethnicity, history of cardiovascular disease, or duration or severity of gout,” said White, according to Managed Care. “A very extensive preclinical evaluation of febuxostat showed no explanation for the excess in sudden cardiac deaths.”
The two drugs carried about the same risk when it came to nonfatal cardiac events including heart failure, arrhythmias, pulmonary embolism, myocardial infarction, and stroke, but Uloric and heart disease fatal events were reportedly linked.
After viewing the initial results of the CARES trials, the U.S. Food and Drug Administration (FDA) made an announcement in November 2017 warning the public through a safety alert that Uloric and heart disease may be linked.
“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA said in their announcement. “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”
In general, Uloric lawsuits are filed individually by each plaintiff and are not class actions.
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