Possible Uloric cardiovascular side effects have led a consumer group to urge the FDA to pull the popular gout drug from the market.

Uloric (febuxostat) is a drug prescribed to treat gout, a type of arthritis caused by uric acid crystal accumulation in the joints, the kidneys, and other tissues. Gout typically manifests first in the big toe, and can appear in foot joints, ankles, and knees. It can cause kidney damage because of uric acid nephrolithiasis and interstitial kidney damage. Gout is typically treated with anti-inflammatory drugs.

Uloric is a drug developed by the company Takeda. Though the drug was initially approved in 2009, only in March of this year was a full review of the drug’s safety released to the public.

Uloric was first rejected by the FDA in 2005 and 2006 because the drug allegedly posed too high a risk to patients’ cardiovascular health. A study of patients who took Uloric showed that nine of twelve deaths that occurred among patients who were studied occurred because of cardiac problems. The study also investigated other gout drugs, none of which were linked to adverse cardiac events or death by a cardiac event.

However, despite this information, the FDA approved Uloric in 2009, requiring that the drug bear a warning label about the possibility of Uloric cardiovascular side effects. At the time, the FDA did say that it intended to conduct a review of a previous safety study that had been conducted on the drug.

It was not until 2017 that the FDA published warnings related to the findings of the study that linked Uloric to cardiovascular side effects. Not until March 2018 did the FDA release their full review, as promised in 2009. In 2018, The New England Journal of Medicine published the safety results, which stated that “all-cause mortality and cardiovascular mortality were higher with febuxostat than with allopurinol.”

As a result of the information published by the FDA on Uloric cardiovascular side effects, the consumer advocacy group Public Citizen petitioned for the drug to be removed from the market in the interest of protecting patients. According to the group, the “serious cardiovascular harms of [Uloric] our weight any purported clinical benefit.”

Public Citizen’s Health Research Group released a statement arguing that the FDA should have demanded that the drug manufactures conduct an appropriate clinical trial of the drug before and not after it gained approval. In the statement, the director of the Public Citizen’s Health Research Group argued that “the FDA almost certainly would have denied approval of [Uloric] if data from this post-market trial had been available at the time of the initial submission.”

If you took Uloric and experienced Uloric cardiovascular side effects, you may have a legal claim. If it is found that Takeda was negligent in the research it conducted for the drug, or if it knowingly endangered patient health by advertising the drug as safer and more effective than it is, the company could be held accountable for patient injury. By participating in a Uloric cardiovascular side effects lawsuit, you could gain compensation for physical, emotional, or finance injury you suffered as a result of your use of the drug.