[ad_1]
Following the review of a post-marketing study, a prerequisite for its approval in 2009, the US regulator added a boxed warning to the etiquette of gout treatment, Uloric (Febuxostat).
The US Food and Drug Administration says the study shows that the risk of death by Uloric is greater than that of allopurinol, a rival drug for gout.
The clinical safety trial, conducted by drug manufacturer Takeda Pharmaceutical (TYO: 4502), showed an increased risk of death from cardiac origin and all-cause death by Uloric.
In addition to the updated safety advice, the FDA limits the approved use of Uloric to certain patients who are not treated effectively or who are experiencing serious side effects with allopurinol.
In patients treated with Uloric, 15 deaths for heart-related causes were observed per 1,000 patients treated for one year, compared with 11 deaths for heart-related causes per 1,000 patients treated with allopurinol for one year. .
In addition, there were 26 all-cause deaths per 1,000 patients treated with Uloric for one year, compared to 22 deaths per 1,000 patients treated for one year with allopurinol.
Source link
