FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare

The U.S. Food and Drug Administration (FDA) has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related death, as well as death from all causes, with febuxostat. The agency has also approved colchicine as an oral solution for prophylaxis of gout flares in adults.

Safety Risk with Febuxostat
The FDA is alerting healthcare providers and patients about the risk of death associated with the use of febuxostat (Uloric), which was approved in 2009 to treat adults with gout. A clinical safety trial found an increased risk of heart-related death, as well as death from all causes, with febuxostat. This finding is a higher risk of death compared with allopurinol.¹

The FDA is updating the treatment’s prescribing information to require a boxed warning.

Healthcare professionals should reserve the use of febuxostat for cases in which allopurinol fails to work and for patients who can’t tolerate allopurinol. Patients should be counseled about the cardiovascular risks of using febuxostat. Advise them to seek medical attention immediately if they experience any of the following symptoms: chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking and/or sudden severe headache.

Patients should tell their healthcare professional if they have a history of cardiovascular problems or stroke. Patients should not stop taking febuxostat without discussing it with their healthcare provider first.

FDA Approves Colchicine Oral Solution
On Feb. 26, the FDA approved colchicine (Gloperba) in an oral solution of 0.6 mg/5 mL for prophylaxis of gout flares in adults.² This treatment form enables easy dosage adjustments for patients, such as the elderly, who cannot swallow solid forms. It also enables renally adjusted doses.

The treatment is cherry flavored and will come in a 150 mL bottle that can be stored at room temperature.³ It’s expected to be available this summer.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. U.S. Food and Drug Administration. Drug safety and availability: FDA adds boxed warning for increased risk of death with gout medicine Uloric (febuxostat). 2019 Feb 19.
2. ROMEG Therapeutics LLC. News release: ROMEG Therapeutics receives FDA approval of Gloperba (colchicine) for prophylaxis of adult gout flares. 2019 Feb 26.
3. ROMEG Therapeutics LLC. Our products: Gloperba. 2019.