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The US Food and Drug Administration (FDA) has added a warning on the label of febuxostat, a drug against gout (Uloric, Takeda) based on the results of a comprehensive post-market safety study.
The FDA concluded that febuxostat increased the risk of death compared to another drug against gout, allopurinol (several brands).
"This conclusion is based on our extensive review of the results of a clinical safety trial that revealed an increased risk of cardiac death and death from all causes with Uloric," the FDA said. in a security communication of 21 February.
The FDA has stated that febuxostat should be reserved for patients for whom allopurinol has failed or who does not tolerate allopurinol. Patients should be advised of the cardiovascular risk associated with febuxostat and the need for immediate medical attention if they experience chest pain, shortness of breath, fast or irregular heartbeat, numbness or weakness. one side of the body, dizziness, difficulty speaking or sudden sensation. , Severe headache.
Gout is a chronic disease that affects about 8.3 million adults in the United States. Febuxostat for gout was approved by the FDA in 2009. The number of drugs to treat gout is limited and the treatment needs for this condition are unmet, the agency said.
In mid-January, as indicated by Medscape Medical News, the FDA's Arthritis Advisory Committee and its Advisory Committee on Drug Safety and Risk Management have decided, to a large extent, to continue to recommend febuxostat to certain patients with 39 hyperuricemia related to gout, despite the post-marketing study.
Since approval in 2009, prescribing information for febuxostat includes a warning regarding possible cardiovascular events in patients treated with the drug. The post-marketing safety study required by the FDA, known as CARES, included more than 6,000 patients with gout treated with febuxostat or allopurinol.
The composite primary endpoint of the study was the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or stroke. Unstable angina with urgent revascularization. Secondary endpoints included individual components of the composite of major cardiovascular events as well as all-cause mortality.
Overall, febuxostat did not increase the risk of these events combined compared with allopurinol. However, when the results were evaluated separately, Febuxostat was found to be associated with an increased risk of cardiac death and all-cause death.
Among patients treated with febuxostat, 15 cardiac deaths were observed per 1,000 patients treated for 1 year, compared with 11 heart-related deaths per 1,000 patients treated with allopurinol for 1 year. In addition, there were 26 all-cause deaths per 1,000 patients treated for 1 year with febuxostat, compared to 22 deaths per 1,000 patients treated for 1 year of allopurinol.
In the modified intent-to-treat analysis, 335 patients (10.8%) in the febuxostat group and 321 patients (10.4%) in the allopurinol group presented a primary endpoint (risk ratio). [HR]1.03; upper limit of the one-sided confidence interval of 98.5% [CI]1.23; P = 0.002 for non-inferiority).
In patients in the febuxostat group, all-cause and cardiovascular mortality rates were higher than allopurinol (RR for all-cause death: 1.22, 95% CI: 1.01 – 1.47, SR for deaths from cardiovascular disease, 1.34, 95% CI, 1.03 – 1.73).
As a result, the FDA will update the febuxostat prescription information with a warning box indicating increased risk and will limit the approved use of the drug to certain patients for whom treatment with allopurinol is not not effective or that have serious side effects with allopurinol.
Health care professionals are encouraged to report adverse reactions or adverse effects related to the use of febuxostat to the FDA's MedWatch safety information and adverse reaction reporting program.
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