FDA Drug Safety Communication on Uloric

PUBLISHED: Feb 22, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on the FDA’s in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.

As a result, the FDA is updating the Uloric prescribing information to require a Boxed Warning, their most prominent warning, and a new patient Medication Guide. The FDA is also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

The FDA recommends health care professionals:

  • Reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above.
  • Monitor for cardiovascular signs and symptoms in patients who are taking Uloric.
  • Counsel patients to seek medical attention immediately if they experience chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking, or a sudden severe headache while taking Uloric.
  • Encourage patients to read the Medication Guide they receive with their Uloric prescriptions, which helps patients understand the cardiovascular safety risks and provides other important information.
  • Report adverse events involving Uloric or other medicines to the FDA MedWatch program.

Follow the link below for additional information.

Want to read the full alert and receive alert emails?

Browse Additional Alerts