FDA Adds Black Box Warning to Gout Medication

Stopping Gout Together Forums Help My Gout! The Gout Forum FDA Adds Black Box Warning to Gout Medication

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    • #8986

      [2-21-2019] 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 our 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, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

      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.1 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
      Numbness or weakness on one side of your body
      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.

      Health care professionals should 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.

      When we approved Uloric in 2009, we included a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric in the current prescribing information and required the drug manufacturer, Takeda Pharmaceuticals, to conduct a large postmarket safety clinical trial. The trial was conducted in more than 6,000 patients with gout treated with either Uloric or allopurinol. 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 intervention, called unstable angina.

      The results showed that overall, Uloric did not increase the risk of these combined events compared to allopurinol (See Data Summary). However, when the outcomes were evaluated separately, Uloric showed an increased risk of heart-related deaths and death from all causes. In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year. In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol. This safety trial was also discussed at a public Advisory Committee meeting of outside experts on January 11, 2019.

    • #9001
      T K

      Be careful with Febuxostat!

      A brother in-law of mine had a severe (life-threatening) stroke recently, and the cause has been traced to Febuxostat/Uloric. He’s only in his mid-40’s and almost left behind a wife and three young kids. He has a long road of rehab ahead and will likely never regain full functionality.

      I’m glad that allopurinol is working ok for me so far (fingers crossed!).

    • #9002

      I wonder what were your in-law’s febuxostat dosage and serum uric acid. I’m not aware of any study taking this into account when looking at side-effects in comparison to allopurinol so it’s not clear allopurinol is inherently less dangerous. Certainly febuxostat is often used in a reckless way.
      Also, were there any warning signs such as chest pain or strange test results?

    • #9003
      T K

      To my knowledge there weren’t any warning signs of the impending stroke, although that doesn’t mean that there weren’t any.

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