FDA Orders Uloric Black Box Warning, Confirms Death Risk

Published on February 25, 2019 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) has ordered a new Black Box Warning for the Uloric label, after a review confirmed that the medication was associated with a higher risk of death compared to other gout treatments.

The agency also ordered Takeda Pharmaceuticals to create a new Medication Guide to explains Uloric heart risks, as well as other important things patients should know about the medication.

“We believe the label updates are appropriate to ensure physicians and patients have comprehensive and accurate information to make informed treatment decisions,” a Takeda spokesperson told FiercePharma.com shortly after the FDA announced its decision.

Uloric Black Box Reflects Findings of Post-Market Study

The FDA approved Uloric (febuxostat) in 2009. At the time, however, the agency ordered Takeda to conduct an additional post-market safety study to better understand its cardiovascular risks.

That study, known as the CARES trial, concluded in November 2017. The preliminary results suggested Uloric increased the risk of cardiovascular death and all-cause mortality compared to allopurinol.

In January, an outside advisory panel recommended that the FDA designate Uloric as a second-line treatment for most gout patients. However, they also asserted that Uloric should remain available for the small number of patients who can’t tolerate allopurinol.

Additionally, the panel recommended a Uloric Black Box Warning to highlight the risk of heart-related death.

FDA Advice for Uloric Patients and Their Doctors

Gout is a chronic form of arthritis that affects approximately 8.3 million adults in the United States. The condition occurs when uric acid builds up in the blood and causes sudden attacks of redness, swelling, and pain in one or more joints.

Unfortunately, there are a limited number of medicines available to treat gout.

According to the FDA, patients considering Uloric should tell their doctors if they have a history of heart problems or stroke. Those taking the medication should seek emergency medical attention right away if they experience 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

Patients should not stop taking Uloric without taking to their doctor, however, as doing so can worsen gout.

Meanwhile, the FDA advised healthcare providers to limit Uloric to patients who have failed or cannot tolerate allopurinol (Zyloprim and Aloprim). They should also discuss Uloric’s cardiovascular risks with these patients.

Does the Uloric Black Box Warning Go Far Enough?

It’s unclear if the Uloric Black Box Warning will protect patients from the drug’s significant risks. In fact, during last month’s advisory panel meeting, one of two dissenting members urged the FDA to pull Uloric off the market entirely.

Public Citizen, which petitioned the FDA for a Uloric recall last June, reiterated that position shortly after the January hearing.

“We disagree with the panel’s vote and urge the FDA to withdraw febuxostat from the market,” Michael A. Carome, MD, director of Public Citizen’s health research group, said in a statement issued after last week’s meeting. “If such action is not taken, the agency should require the addition of a black box warning about the increased risk of cardiovascular death and modify the approved indication to limit use of the drug to patients who are not able to use allopurinol.”

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