In the concern surrounding the risk of serious Uloric adverse reactions, a nonprofit advocacy group has called for the FDA to recall the gout medication from the market.

Advocacy group Public Citizen stated that the drug was unreasonably dangerous to patients, and cited the need to recall the medication after a postmarket study analyzed serious Uloric adverse reactions.

Released into the market in 2009, manufacturer Takeda Pharmaceuticals released initial clinical trials that evaluated Uloric adverse reactions including heart attack, stroke and cardiac related deaths.

It is important to note that the FDA initially rejected Uloric (febuxostat), due to Uloric adverse reactions being linked to cardiovascular problems. While these Uloric adverse reactions were included on the drug’s warning label, the FDA required Takeda to perform a follow up study after the medication was released.

It was the results of this postmarket study that spurred Public Citizen to reach out to the FDA, calling for Uloric to be recalled from the market. The results of this post market study reportedly indicated that Uloric patients faced an increased risk of cardiovascular events, along with an overall increased risk of death.

Overview of Uloric Adverse Reactions

The CARES study results were published on March 12, 2018 in the New England Journal of Medicine (NEJM), which coincided with the presentation at the American College of Cardiology (ACC) 2018 Annual Scientific Session.

According to Medscape, the study compared potential cardiovascular complications in conjunction with febuxostat and allopurinol use in over 6,100 patients that were at risk for cardiac complications and had taken the drug for an average of two and half years.

While Uloric adverse reactions did not show a statistically significant risk for cardiovascular risk, however, there was an increased risk of death in general, with the majority of them being cardiovascular deaths.

The FDA announced the CARES outcomes in November 2017 in a public safety announcement, which stated that there was an increased risk of “heart-related deaths and death from all causes” in conjunction with Uloric adverse reactions.

These postmarket results spurred Public Citizen to file a petition on June 21, 2018 to have Ulroic recalled, stating that the CARES study provided “overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit.”

Medical experts from the Public Citizen state that the FDA would not have approved febuxostat if the agency had been aware of the severity of potential Uloric adverse reactions. Takeda Pharmaceuticals is reportedly aware of the petition and has declined to comment, but agrees that further cardiovascular deaths must be prevented.

Even with the CARES study results and recall petition, some medical experts argue that there is still reason to keep Uloric on the market. According to Dr. Eileen Handberg of the University of Florida,  there was no definitive proof between the medication and increased risk of serious health complications.

Dr. Handberg further stated that Uloric and other popular treatment medications each carried the risk of side effects. Dr. Handberg ultimately called for more research to be conducted, before it was decided whether or not Uloric would be recalled from the market.