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FDA warns- Febuxostat increases mortality risk, use it sparingly


FDA warns- Febuxostat increases mortality risk, use it sparingly

The US Food and drug administration after conclusion of a months-long investigation into mortality risk with Febuxostat (Uloric) issued a mandating strong warnings on the product label and restricting use.It has been categorically stated that approved  use of febustat  is now only after maximally titrated allopurinol (Zyloprim) fails or isn’t tolerated.

Febuxostat (Uloric) was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S. The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

Patients should tell your health care professional if you have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat your gout. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbnessor weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache
  • Do not stop taking Uloric without first talking to your health care professional, as doing so can worsen your gout.

Moreover henceforth Febuxostat will have to carry a black-box warning of increased risk of cardiovascular and all-cause mortality compared with allopurinol, as had been shown in the CARES trial, and update the patient medication guide with that information.

FDA also recommended that clinicians monitor for cardiovascular signs and symptoms for patients on febuxostat.

Since approval in 2009, the label has warned of increased risk of gout flares with initiation of therapy, cardiovascular events, hepatic toxicity, and serious skin reactions.

The additional precautions follow the recommendations of the FDA advisory panel that met in January. It had overwhelmingly voted that the benefits still outweigh the risks for selected patients who had  serious skin reactions to allopurinol.


Source: self

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  1. user
    Dr. Kenny Thomas; MD, MHSc. February 23, 2019, 6:35 pm

    Can you give the reference for the CARES trial.
    Personally have not encountered any significant side-effects with Febuxostat & I usually stop as soon as Uric Acid levels have decreased. Pts.then continued on a low purine diet.