The FDA warning: gout drug resistance of cloth division he or increases the risk of cardiovascular death

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in 2017, the FDA drug safety statement released on November 15, remind the public attention, is a single, according to preliminary results of safety testing gout drug resistance not cloth company he has triggered a significantly higher risk of cardiac death don’t Piao alcohol. in 2009, the FDA approval of the cloth division he (brand name Uloric) requires producers takeda pharmaceuticals for the safety study, and will be started immediately when get the final result comprehensive review, and update the related information to the public.

at the same time, the FDA in its announcement to remind patients with medical staff in considering whether to enable or continue to use the cloth when he seriously about the security information, must inform medical staff and patients themselves whether there is any questions or concerns, but also points out that the patients before the withdrawal must seek medical staff’s advice and opinion.

due to the public before clinical trials, according to the results of not cloth company he heart correlation is higher than the incidence of adverse reactions caused by don’t Piao alcohol, so the FDA on cardiovascular events in the drug instructions to the boxed warning. Described in heart related adverse reactions include: heart disease, stroke, and cardiac death. As a result, the FDA requires takeda pharmaceuticals in the cloth after he approed for added safety research, the research on security recently completed .

described the safety of the study of 6000 patients with gout be the cloth division him or don’t Piao alcohol treatment. Main clinical end point was cardiac death, nonfatal heart disease, nonfatal stroke and in need of urgent surgical treatment of composite incidence of cardiac blood events. Preliminary results show that the cloth division him group although the adverse reaction of integrated risk is not higher than don’t Piao alcohol group, but for a separate analysis of the above events and found that compared with don’t Piao alcohol, not cloth company he will rise and cardiac death in patients with all in risk of death. , according to data from the

at present, the patients with high uric acid hematic disease, 2 million or so, and the current drop uric acid drugs, there are only three: benzene bromide Malone, don’t Piao alcohol and the cloth company him, don’t Piao alcohol and not cloth company which are drugs inhibit acid production. not cloth company he listed in China in 2013, because of its compounds for patent in China, so there were several generic CFDA approval.

after the domestic healthcare professional BBS & other; Clove garden & throughout; , also has the doctor of the cloth division him to discuss the clinical use, concurrent titled “the use of cloth division he: five kinds of mistakes easily into this” article, full text articles below & ndash; & ndash;

the drop uric acid treatment for patients with gout, 2016 edition of “Chinese gout guidelines” (hereinafter referred to as the “guidelines”) will not cloth division, he in the moderate recommendation. Because of its clinical curative effect is good, the cloth he has become an endocrinologist, the li rheumatism lead of the common medicine. However, the author observed in the use of cloth division, easily in the indication, usage, adverse reactions and so on into the erroneous zone.


high uric acid hematic disease need drop uric acid treatment, all can use the cloth division him 1. The cloth division him the most suitable type uric acid to generate too much

2013 edition of “high blood uric acid and gout treatment China expert consensus” (hereinafter referred to as the “agreement”), according to the situation of blood uric acid level and urinary uric acid excretion, high uric acid hematic disease can be divided into three type: uric acid excretion bad type, excessive uric acid to generate the type and mixed type.

the cloth division him through selective inhibition of xanthine oxidase, reduce the generation of uric acid and decreases the blood uric acid level, the most suitable type uric acid to generate too much. Therefore, before the choose the cloth company him, conditional word, best to return the 24 h urine check urine uric acid, to determine the type of high uric acid hematic disease.

2. Do not recommend the cloth division him for asymptomatic high uric acid hematic disease

in addition, the cloth division his instruction and “consensus” indicates the fabric department he applies to patients with gout and high uric acid hematic disease, and is not recommended for asymptomatic high uric acid hematic disease. The drug did not applied to the secondary research in patients with high uric acid hematic disease, so secondary high uric acid hematic disease patients is not recommended.


40 mg daily of cloth he, check again after 1 month of taking the blood uric acid

“consensus” and recommended instruction: oral starting dose of 40 mg, 1 times a day. Due to the fabric department with the formation of xanthine oxidase drugs – enzyme complex extremely stable, its lower uric acid effect more strong than allopurinol, it take 2 weeks to review the blood uric acid.

if after 2 weeks, blood uric acid level is still not less than 360 & mu; Mol/L, it is suggested that the dose increased to 80 mg, 1 times a day.

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