The gout treatment drug Uloric (febuxostat) has recently been linked to cardiac complications, which spurred the FDA into sending out urgent safety letters to the medical community and general public.

These two safety communications were released on Nov. 15, 2017, with one letter stating the popular drug Uloric has been linked to increased risk of certain cardiovascular events, and the second letter stating the agency would be evaluating all potential deaths linked to the drug Uloric.

Gout is an arthritic condition that primarily affects the patient’s feet, due to the build up of uric acid in the blood. Gout patients, who have described the pain as their big toe being lit on fire, seek out medical treatment to ease the pain and treat the condition.

The drug Uloric is a popular choice for this, with its treatment mechanism directly reducing the level of uric acid. Combined with diet and exercise, the drug Uloric has helped millions of gout patients.

The drug’s popularity makes the FDA’s warning all the more troubling, as numerous patients could be at risk for cardiovascular events. The FDA released this warning after a follow-up post market clinical trial found the drug Uloric had increased risk of nonfatal stroke, heart attacks, and cardiac ischemia.

However, the trial also indicates a potential for fatal cardiac events and even sudden death for more at risk patients.

Overview of Uloric Cardiovascular Events

The clinical trial for Uloric was performed by Chicago-based pharmaceutical giant Takeda Pharmaceuticals, the drug’s manufacturer; it consisted of 6,000 gout patients. Half of the subjects were prescribed Allopurinol and the other half of patients were prescribed the drug Uloric, with researchers looking to compare the medications’ side effects and potential health risks.

The study showed that Uloric patients had shown a higher likelihood of nonfatal stroke, heart attack, and cardiac ischemia, and that the patients needed emergency surgical intervention. This study was conducted after previous pre market clinical trials had indicated risk for heart attack and other cardiovascular events, which spurred the FDA to request this follow up study.

Even though there was concern about Uloric’s side effects, the medication was approved in 2009 with the warning label describing potential cardiac risks. In light of the post market study results, the FDA recommends that current Uloric patients discuss these potential cardiac risks with their physicians.

In addition, physicians are encouraged to thoroughly evaluate patients before prescribing them the drug Uloric. Even with Uloric’s alleged association to increased risk of cardiovascular events, patients should not discontinue their medication without consulting their physician.

Even though Takeda Pharmaceuticals had given full disclosure to the FDA, the company is currently facing intense public scrutiny for the drug Uloric. Class action investigators are currently evaluating claims made against the company, which allege Takeda had deliberately downplayed the risks of their drug Uloric.

Numerous patients are alleging various product liability claims such as negligence, stating they were unaware of the increased risk for cardiac events. Uloric patients or their loved ones that experienced these serious side effects should speak to a lawyer to determine eligibility for joining a class action lawsuit or filing their own claim.