Some consumers claim that Takeda hid the evidence regarding Uloric cardiovascular risks in order to protect themselves and their profits.

Although arthritis is typically seen as joint pain affecting large joints such as the hips and knees, there are several types of arthritis which show up in different ways.

Gout is one form of arthritis which affects the joints of the fingers and toes and is associated with a buildup of uric acid. Uric acid is a natural cellular byproduct but people with gout are unable to sufficiently process uric acid out of the body. The buildup of uric acid in the joints can cause sharp, needle-like crystals.

Gout symptoms may vary but commonly include severe inflammation, intense joint pain, lingering discomfort, inflammation, redness, and limited range of motion. For some patients, the condition can be managed through diet and other lifestyle changes to help with inflammation. However, some patients may need to take a specialized gout drug to treat their condition.

One medication available to treat gout is Uloric, a drug developed by Takeda Pharmaceuticals to be a safer alternative to allopurinol. Allopurinol was a popular treatment option for gout patients until studies revealed that the medication was associated with severe allergic reactions and kidney problems.

Although Uloric does not carry the same risks as allopurinol, scientific evidence suggests that the drug may be associated with Uloric cardiovascular risks.

Clinical trials reportedly showed that Uloric cardiovascular risks may be associated with the drug, prompting the U.S. Food and Drug Administration (FDA) to order a new study to examine the risks. The Uloric cardiovascular risks study examine data from 6,000 patients taking either allopurinol or arthritis to treat their gout symptoms.

In November 2017, the FDA released a safety alert with the results of the study and informed the public that “the primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery”.

The study revealed that the gout medication was associated with serious Uloric cardiovascular risks which could be life threatening. Additionally, cardiac conditions often require regular monitoring. Without any warning, Uloric patients were unable to keep a close eye on their health to monitor for Uloric cardiovascular risks.

Although the idea of being at risk for cardiovascular death is terrifying, the FDA urges Uloric patients to not stop their medications without consulting with a doctor first.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA said in their 2017 safety warning. “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

The 2017 safety alert was not the first time that Takeda faced accusations of failing to warn consumers. In 2012, a former Takeda safety consultant filed a whistleblower lawsuit claiming that the pharmaceutical company concealed data from the FDA regarding Uloric cardiovascular risks.

2019 Update to FDA Warning

The FDA has updated the prescribing information for gout drug Uloric to warn patients that there is an increased risk of death when taking that drug as opposed to other gout drugs. Now, there will be an FDA Boxed Warning, the most prominent warning, present on all Uloric medication. Additionally, the medication guide for Uloric will be updated to reflect this information. 

When the drug was approved initially in 2009, the FDA did include a Warning and Precaution about possible cardiovascular events connected with use of the drug.

A study conducted by the drug’s maker, Takeda Pharmaceuticals, after its approval indicated that the drug could be connected to adverse cardiac events including death by heart failure. However, that research did not indicate that this risk was higher than risks associated with allopurinol, another gout drug according to Pharmacy Times.

But, the FDA reports that when the risks and cardiac events connected with Uloric are examined separately, there is an elevated risk over allopurinol, spurring the FDA to update its warning. The decision to update the warning to a Boxed Warning was made after a public Advisory Meeting was conducted on January 11, 2019.

With this new, more severe warning, the FDA advises that Uloric should only be used for patients who did not respond effectively to other gout treatments, or who experienced severe side effects with allopurinol.

In the interest of increasing the FDA’s understanding of Uloric’s impacts and risks, the FDA urges patients and medical professionals alike to report side effects and symptoms associated with Uloric.