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Increased Death Risk Prompts Boxed Warning for Gout Drug

 

By Jonathan Block

February 25, 2019

Increased Death Risk Prompts Boxed Warning for Gout Drug

Doctors should avoid prescribing the popular gout drug Uloric (febuxostat) in favor of Zyloprim (allopurinol) since there is an increased risk of death associated with Uloric, according to an FDA warning.

The FDA says its review of a postmarket trial of 6,000 patients comparing Uloric to Zyloprim found that Uloric was associated with an increased risk of heart-related death, as well as deaths from other causes, compared to Zyloprim. The analysis showed that there were 15 deaths per 1,000 people from heart-related causes for those in Uloric compared to 11 per 1,000 on Zyloprim.

As a result, the agency is requiring that the drug’s label contain a “black box” warning – the FDA’s most severe – warning of this risk. The FDA added that Uloric should be reserved for patients who fail on or who can’t tolerate Zyloprim. This essentially relegated Uloric to a second-line treatment.

Last year, consumer advocacy group Public Citizen urged the FDA to pull Uloric from the market. Uloric is also known to cause joint and muscle pain, as well as nausea.

 

Last updated: February 25, 2019