Studies show that Uloric used for the treatment of gout has resulted in an elevated risk of death from cardiac arrest or stroke in patients compared to allopurinol, the first-line treatment. In February 2019, the FDA began requiring packages of Uloric to carry a “black box” warning about these risks.

Uloric labeling had carried a Warning and Precaution statement about these risks previously, as clinical trials conducted prior to FDA approval in 2009 had revealed a higher risk of adverse cardiac events.

As one of the conditions of approval, the FDA mandated that drug maker Takeda Pharmaceuticals conduct post-marketing safety studies. The results, published in November 2017, confirmed what clinical trials had indicated: patients treated with Uloric faced an elevated risk of dying from a heart attack or stroke as well as other causes. As a result, the FDA began requiring that the Uloric label be updated with its most prominent warning, and limited its approval to patients who either fail to respond or experience adverse reactions to allopurinol.

How Long Has Uloric Been Available?

The medication known as febuxostat (the generic name for Uloric) was first developed in 1998 by chemists at Japanese pharmaceutical company Teijin Ltd.  Eventually, Teijin entered into partnerships with Takeda’s U.S. division, TAP Pharmaceuticals, and a European company, Ipsen Pharma. Ipsen, which specializes in medications for rare diseases, was able to get approval for the medication from the European Medicines Agency in 2008. Uloric was approved by the FDA for the U.S. market the following year.

How Does Uloric Work?

Uloric, according to Science Direct, is used for gout operates by lowering levels of blood uric acid levels, which causes the symptoms of gout. Uloric (scientific name, febuxostat) is known as a xanthene oxidase (XO) inhibitor. XO plays a significant role in the production of uric acid.Most patients take a 40 mg dose per day; if deemed necessary, a physician may prescribe twice that dosage. The most common side effects include headaches, nausea, joint pain and skin rash. It is contraindicated for patients with impaired liver or kidney function, previous history of cardiac arrest or stroke, and women who are pregnant or breastfeeding.

What Else is Uloric Used For?

Aside from the treatment of gout, Uloric may be prescribed for patients who suffer from high levels of uric acid due to other causes.Known in medical parlance as hyperuricemia, abnormally high uric acid levels in the blood can be caused by insulin resistance (type-2 diabetes), excessive iron, high blood pressure, low thyroid acticity, impaired kidney function, obesity, a diet rich in fatty foods and too much alcohol. In fact, gout was once known as the “Disease of Kings”; reportedly, King Henry VIII of England suffered from the disorder.Cancer patients may also suffer from hyperuricemia as a result of chemotherapy. When a high number of cancer cells are killed off at once, resulting in a condition called tumor lysis syndrome, it can cause high uric acid levels.

Are There Other Serious Side Effects of Uloric?

Aside from the risk of adverse cardiovascular events, Uloric is linked to liver damage and inflammation. According to the Mayo Clinic, this can result inelevated liver enzymes
.

Is Uloric More Effective Than Allopurinol?

At the standard dosage, Uloric can be more effective than allopurinol. However, at higher dosages, there was no appreciable difference in efficacy between Uloric used for gout treatment and allopurinol.

Is There an Alternative to Uloric?

Aside from allopurinol – which carries its own risks and interacts with many other medications – there is a non-steroidal anti-inflammatory drug (NSAID) known ascolchine
, a derivative of the autumn crocus plant (also known as meadow saffron), which, according to the Mayo Clinic, has been used in folk medicine for more than 3500 years for joint swelling.

Side effects of colchine are few and relatively minor. However, Colchine must not be taken by patients with impaired kidney function, as up to 20 percent of a dose is simply passed through the urine and cannot be removed with dialysis. Colchine can be toxic in patients with kidney failure, as it accumulates in the tissues and bloodstream. Consequences of colchine toxicity include bladder pain syndrome, anemia, nerve damage (polyneuropathy) as well as bone marrow and muscle tissue injury.

Have There Been Uloric Lawsuits?

In 2010, Dr. Helen Ge, a Takeda employee filed a whistleblower lawsuit, alleging that the company had been aware of the deadly side effects and had concealed this information from the public. Ultimately, Takeda’s lawyers were able to get the suit dismissed on a technicality. However, in March, 2018, the New England Journal of Medicine published the results of a study that confirmed Dr. Ge’s earlier claims about the link between cardiovascular issues and gout medication. Plaintiffs in current Uloric litigation claim they suffered cardiovascular injuries as a result of taking the drug, and that they were not warned of the risks. These lawsuits are in their early stages; no verdicts or settlements have been delivered at this time.