FDA Approves First New Gout Drug in 40 Years
It’s been 40 years since the US Food and Drug Administration (FDA) approved a new drug for treating gout but the new drug, Uloric (febuxostat), has just passed the test, according to Takeda Pharmaceuticals, maker of Uloric. A daily dose of the drug, taken orally, is recommended for management of chronic hyperuricemia in patients with gout.
Gout, a painful disease affecting the joints, is caused by a build-up of uric acid. Uloric inhibits the enzyme, xanthine oxidase, thereby minimizing production of uric acid. This decreased uric acid production lowers the acid level in the body and reduces the pain caused by elevated uric acid levels.
Safety questions were raised in 2005 when Takeda first submitted Uloric for FDA approval. At that time, Uloric was thought to cause heart problems and death in more patients than allopurinol does. Allopurinol is the most commonly prescribed drug for gout at this time.
Takeda expanded its study of Uloric, conducting a phase III clinical trial involving even more gout patients than were included in both phase III trials conducted at that time. The new findings indicate Uloric is no more likely to cause heart disease or death than allopurinol is. The drug earned its current FDA approval based on these findings, along with the requirement that these safety issues are discussed with the patient.
According to Takeda, Uloric’s most common adverse side effects, as identified during its clinical trials, include abnormalities in liver function tests, joint pain, nausea, and rashes.
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[...] FDA Approves First New Gout Drug in 40 Years Takeda expanded its study of Uloric, conducting a phase III clinical trial involving even more gout patients than were included in both phase III trials conducted at that time. [...]
This is very up-to-date information. I’ll share it on Digg.
If DFA already approves this product and is proven effective, then it will be a safer thing to use in order to treat this painful disease - Gout!
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