ULORIC AND FDA BLACK BOX WARNING

Gout, a form of arthritis, affects roughly 8.3 million people in the U.S., according to the FDA, yet few medications are available to treat the chronic disease. While Uloric was marketed in 2009 as the first new treatment option for patients in more than 40 years, studies have suggested that any benefit of the drug may come at an extreme risk.

The FDA announced in February 2019 that the results of a safety clinical trial found an increased risk of heart-related  death and death from all causes with Uloric compared with another gout medication, allopurinol. The trial, which involved more than 6,000 patients, found 15 deaths from heart-related causes for every 1,000 patients who took Uloric for a year, compared with 11 deaths for those who took allopurinol, according to the FDA. There were also 26 deaths from any cause for every 1,000 patients who took Uloric for the same time period compared with 22 deaths for those who took allopurinol.

In response to what it found to be an increased risk associated with Uloric, the FDA issued a black box warning for the drug — the agency’s most prominent warning reserved for products that could cause serious injury or death. The FDA also restricted Uloric to treat only certain patients who do not respond or experienced severe side effects while taking allopurinol.


What is Uloric and why is it so dangerous?

Made by the international conglomerate Takeda Pharmaceuticals, Uloric (febuxostat) is a medication that lowers uric acid levels in the blood. It was first FDA approved in 2009 as an alternative to treating gout with allopurinol.

After approval, the FDA required Takeda to conduct a large post-market study of the gout medication to evaluate the cardiovascular safety of the medication. According to the Agency, results from the 6,000 patient post-market study of gout treated with either Uloric or allopurinol showed that Uloric did not increase the risk of these combined cardiovascular events compared to allopurinol. However, when the outcomes were evaluated separately, Uloric showed a significantly increased risk of heart-related deaths and death from all causes.

The FDA is now taking steps to warn the public by updating Uloric’s prescribing information and medication guide as well as requiring a Boxed Warning, the FDA’s most prominent warning for pharmaceuticals.


Possible Uloric Symptoms

It is recommended those taking Uloric seek immediate emergency medical attention if they are experiencing any of the following symptoms:

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


Uloric Heart-related Complications

Patients who take Uloric may experience severe heart-related complications, such as:

  • Heart-related death
  • Stroke
  • Heart attack

TRUST NICKS LAW FIRM

If you or a loved one experienced a heart-related complication while taking Uloric, you need to call Attorney Shantrell Nicks of the Nicks Law Firm today at (228) 896-6425.