Febuxostat gout medicine can cause heart disease
The US Food and Drug Administration (FDA, Food and Drug Administration) has decided to publish a warning on the label for the anti-gout drug (Uloric, Takeda). Such actions are based on the results of a large safety study.
The FDA concluded that there is an increased risk of death from febuxostat compared with another gout medication, allopurinol.
“This conclusion is based on our in-depth review of the results of a safety clinical trial, which revealed an increased risk of death from cardiovascular disease when using Uloric,” the FDA said in a February 21 report.
The FDA notes that febuxostat should be administered only to those patients with gout who for some reason have not approached allopurinol or have been intolerant to allopurinol. Also, patients should consult about the risk of cardiovascular diseases when using febuxostat. If, against the background of his intake, chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking or sudden, severe headache are experienced, consult a doctor immediately.
Gout is a chronic disease that affects approximately 8.3 million adults in the United States. The FDA approved febuxostat for the treatment of gout in 2009. The number of drugs for the treatment of gout is limited, and there is an unmet need for treatment of this disease, the agency said.
Since its approval in 2009, information on the prescription of febuxostat has included a warning about possible cardiovascular diseases in patients receiving the drug. The safety study, known as CARES, involved more than 6,000 patients with gout who were treated with either febuxostat or allopurinol. The primary results of the study were based on the first cases of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina pectoris with urgent revascularization. Secondary results included individual components of the underlying cardiovascular disease, as well as mortality for any reason above.
In general, febuxostat did not increase the risk of developing these combined events compared with allopurinol.However, when the results were evaluated separately, it was found that febuxostat is associated with an increased risk of death from cardiovascular disease and death from all causes. Among patients treated with febuxostat, 15 deaths from cardiovascular diseases were observed for every 1,000 patients treated for 1 year, compared with 11 heart-related deaths for 1,000 patients treated with allopurinol for 1 year. In addition, there were 26 deaths from any cause per 1000 patients who received fabuxostat for 1 year, compared with 22 deaths per 1000 patients who received allopurinol for 1 year.
In connection with the results obtained, the FDA will update the information on the appointment of fabuxostat in the form of a warning on the funds box with a note of increased risk. There will also be limited approval for use of the drug by some patients for whom allopurinol treatment is ineffective or who experience serious side effects with allopurinol.
Healthcare providers are encouraged to report adverse events or side effects associated with the use of febuxostat to the FDA MedWatch safety information and adverse event program.
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