FDA Says Trial Results Show Gout Drug Uloric Poses Increased Risk of Heart-Related Death

WASHINGTON, D.C. — The Food and Drug Administration has issued an alert that preliminary results from a safety clinical trial show an increased risk of heart-related death with Takeda Pharmaceuticals’ gout drug Uloric (febuxostat) compared to its competitor drug, allopurinol.

In a Nov. 14 Drug Safety Communication, the agency said it required Takeda to conduct the safety study when Uloric was approved in 2009. Once Takeda receives the final results, the FDA will conduct a comprehensive review and update the public with any new information, the alert says.

“The safety trial was conducted in over 6,000 patients with gout treated …