Gout Drug Uloric Linked to Heart Attack Risk

A number of product liability attorneys are now looking into potential Uloric lawsuits, suggesting that the controversial gout medication may be the target of mass litigation following recent revelations of that users were not adequately warned about the risk of heart problems and death.

In late February, the FDA announced it would require a new boxed warning be added to all Uloric labels, alerting consumers and the medical community about the risk of cardiovascular injury and overall death. It is the strongest warning the agency can require a drug maker to place on their product.

Uloric (febuxostat) was introduced by Takeda Pharmaceuticals as a safe medication, which is designed to lower the blood uric levels among adults diagnosed with gout. Amid aggressive marketing, the drug has rapidly become a blockbuster over the past 10 years. However, recent research suggests that users may face serious heart risks when compared to alternative gout treatments.

In the wake of the warning, concerns are being raised that the manufacturer failed to adequately warn the medical community and patients about the true side effects of Uloric, despite warning signs that have existed for several years.

A few different plaintiffs’ attorney groups have organized meetings or conferences in the coming weeks about the potential Uloric litigation, to discuss criteria for claims that can be maintained and develop plans for the litigation.

While there were some warning signs and even FDA concerns when Uloric was first released, it appears that the agency did not understand the true scope of Uloric heart problems until Takeda released the results of a post-marketing clinical trial the FDA required the drug maker to complete when approving Uloric in 2009. However, growing evidence suggests that Takeda knew or should have known about the risks, yet continued to market the drug without adequate warnings.

The FDA has now required that a prominent label warning be placed on Uloric, and doctors are advised to only consider use of the drug if patients are not able to tolerate allopurinol, an older and safer gout treatment.

Result from the Takeda clinical trial compared Uloric and allopurinol, finding that for every 1,000 patients treated for a year with Uloric there were 26 deaths, compared to only 22 with allopurinal. However, when examining the risk of heart-related deaths, there were 15 Uloric deaths for every 1,000 patients treated for a year, compared to 11 with allopurinol.

Although a Uloric recall was urged by some critics, the FDA decided to allow the drug to remain on the market, with severe limitations approved uses.

Plaintiffs lawyers suggest that if Takeda has provided earlier warnings, many consumers may have avoided suffering a heart attack, stroke or wrongful death by using other gout treatments.