Health Canada's approval of ULORIC was based on multiple phase III clinical trials. A diverse patient population of more than 4,000 subjects was studied, and in some cases for up to five years. ULORIC has a proven safety and efficacy profile that makes it an appropriate option for patients who have elevated sUA (serum uric acid) levels, have mild-to-moderate renal or hepatic impairment, or are unresponsive to other treatment options.
"Takeda is committed to striving toward better health for individuals by providing innovative therapies," says Paul Friel, general manager and president, Takeda Canada, Inc. "We are pleased to offer a new treatment option, the first in 40 years, to patients with gout as a way to help treat their underlying medical condition and provide them relief from this intensely painful disease."
ULORIC has an established safety profile with no dose adjustments required in patients with mild-to-moderate renal or hepatic impairment. As with all medications, ULORIC has an established risk to benefit profile and so patients should speak to their physician to determine if ULORIC is right for them. The possible side effects that can occur in people who use ULORIC include liver problems, diarrhea, nausea, dizziness, joint pain, gout flares, and rash. Also, a small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events. ULORIC is not recommended for the treatment of high uric acid without a history of gout.
Source: TAKEDA CANADA, INC.