Uloric is a gout drug also known by its generic name, febuxostat. Though the drug can offer relief from uncomfortable symptoms of gout, it can pose problems of its own. For some patients, these risk may outweigh the drug’s benefits.

Mayo Clinic notes that gout is a common but complex form of arthritis that occurs when urate crystals accumulate in a joint, causing inflammation and pain. Uloric treats gout by reducing the amount of uric acid in the blood, which in turn reduces the likelihood of urate crystals accumulating. The drug is taken by mouth, usually once daily.  

Gout can have a range of unpleasant symptoms including intense or lingering joint pain, inflammation, redness, and a limited range of motion. The condition often presents as pain in the joint at the base of the big toe. This pain may appear suddenly, and linger for several hours before decreasing. Attacks of gout can come on without warning, often at night. Following the initial painful attack, many sufferers of gout will experience discomfort for days or weeks after.

These symptoms reportedly can worsen as the condition progresses. Gout drugs like Uloric work to decrease these symptoms, but they reportedly can have side effects that can cause discomfort or pose more serious risk.

Approximately 8.3 million adults in the U.S. are affected by gout, which can be debilitating for some sufferers. There is a lack of treatment options for people who suffer from gout, leaving many of them to make the choice between experiencing the painful symptoms of the condition or taking medications that may come with dangerous side effects. While limiting the amount of alcohol, red meat, seafood, and sugar may help to reduce the symptoms of gout, many people with the condition rely on these medications to manage their symptoms.

In November 2017, the FDA added a boxed warning to the label for Uloric to alert patients that this drug is associated with a higher risk of death than another gout medicine, allopurinol. Reportedly, this increased risk of death was found in cases of death from heart related causes, as well as death from all other causes.

The FDA notes that the boxed warning is the most prominent type of warning, meant to give patients all the information they need to make an informed choice when using the drug.

Additionally, the FDA is coming out with a new patient Medication Guide to provide further information about the drug, and are limiting the approved uses of Uloric to certain patents who “are not treated effectively or experience severe side effects with allopurinol,” the gout drug with a lower risk of death.

According to the FDA, the following symptoms may indicate a serious problem in Uloric patients:

• Chest pain
• Shortness of breath
• Rapid or irregular heartbeat
• Numbness or weakness on one side of your body
• Dizziness
• Trouble talking
• Sudden severe headache

Reportedly, there was concern about cardiovascular problems related to Uloric when the drug was first approved in 2009. Later research conducted on the drug after its approval only increased concern about the risks associated with the gout medication.

Healio reports that despite these risks, a joint panel of the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee determined that the benefits of fexbuxostat (Uloric) outweighed the risks, so it should stay on the market.

Reportedly, most of the panels did say that the drug should be a “second line therapy” for treating hyperuricemia (an excess of uric acid in the blood) in gout, and should not be the first option for treating gout because of the issues it poses. American Family Physician notes that hyperuricemia can exist separately from gout, but the two are often linked. 

Uloric’s maker, Takeda, defends the drug despite concerns from the medical community. Senior Vice President and Head of Global Regulatory Affairs said that “we have studied the safety of Uloric for more than 15 years, and remain confident in Uloric as an important option for the chronic management of hyperuricemia in gout.”

FDA Action

Net News Ledger reports that the FDA has made a move to increase the warnings associated with Uloric in 2019. The news source says that, in addition to death risks, Uloric will now be required to include a Boxed Warning and a new patient Medication Guide that will inform patients of the possible side effects of taking the drug.

According to the announcement made by the FDA in 2019 regarding the new boxed warning for Uloric, the drug was found to increase the likelihood of death by any cause, and prescriptions for Uloric will now be limited to people for whom allopurinol does not work.

This change was inspired by research that involved conducting interviews with over 6,000 patients, and observing them for almost three years. It was also influenced by the many Uloric lawsuits by patients who say that they were injured by the drug and its alleged side effects, including cardiac problems. Uloric lawsuits have also been filed by the relatives of patients who have died allegedly as a result of Uloric side effects.

A nonprofit reportedly requested the FDA remove Uloric from the market, over possible problems with the drug. Net News Leger says that the FDA denied this petition, despite mounting evidence that Uloric could cause serious side effects.

Net News Ledger goes on to explain that Uloric has long been used as a first line of treatment for gout, and even was among the United States’ top 50 most recommended medications.  According to the publication, Takeda marketed Uloric aggressively to counteract the effects that the warnings had on the drug’s sales. Now, in light of the FDA’s actions, Uloric is recommended as a second line treatment, to be used after other treatment options have failed.

Unfortunately, many people who switched from Uloric to a different gout medication, allopurinol, may also be at risk of developing complications. Although allopurinol is believed to be safer than Uloric, the drug comes with its own rare yet serious potential side effects, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.