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FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

[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
Dizziness
Trouble talking
Sudden severe headache

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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.

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To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving Uloric or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Facts about Uloric (febuxostat)

Uloric is approved 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.
Common side effects of Uloric include nausea, rash, joint pain, gout flares, and liver problems.

6 Ways to Deal with Painful Gout Attacks

It’s difficult to focus on work or other daily activities when you’re experiencing gout inflammation and pain. Symptoms can last for a few days or even weeks, with the worst pain usually occurring in the first day or two.

While the best thing to do is talk to your physician, there are several steps you can take right away ease your gout symptoms:

Excess uric acid in the bloodstream can lead to the formation of uric acid crystals in one or more joints, resulting in gout. Read: All About Gout — Symptoms, Diagnosis, Treatment

1. Take an NSAID (but not aspirin)

Over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, can help relieve gout pain. Avoid aspirin and other medications that contain acetylsalicylic acid, which can make your gout worse. 1 Ben Salem C, Slim R, Fathallah N, Hmouda H. Drug-induced hyperuricaemia and gout. Rheumatology (Oxford). 2017 May 1;56(5):679-688. doi: 10.1093/rheumatology/kew293 Keep in mind NSAIDs carry potential side effects, such as an increase in blood pressure, 2 Snowden S, Nelson R. The effects of nonsteroidal anti-inflammatory drugs on blood pressure in hypertensive patients. Cardiol Rev. 2011 Jul-Aug;19(4):184-91. doi: 10.1097/CRD.0b013e31821ddcf4 , 3 Aljadhey H, Tu W, Hansen RA, Blalock SJ, Brater DC, Murray MD. Comparative effects of non-steroidal anti-inflammatory drugs (NSAIDs) on blood pressure in patients with hypertension. BMC Cardiovasc Disord. 2012;12:93. Published 2012 Oct 24. doi:10.1186/1471-2261-12-93 so discuss this treatment with your doctor.

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2. Take your prescription drugs

If you’ve had a gout attack before, your physician may have prescribed drugs to treat attacks. This may be your first line of defense or you may decide to use them only when NSAIDs fail to relieve your pain.

Prescription medications to treat gout include:

Prednisolone oral tablets, which has been shown to work as well as NSAIDs and often doesn’t cause the same stomach upset. Prednisolone is a type of corticosteroid and does carry other potential side effects, particularly if it is taken for longer than the recommended 5 days. 4 InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-. Gout attacks: Pain relief. 2015 Mar 11 [Updated 2018 May 17]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK284948/
Colchicine, which has been shown effective in reducing pain and inflammation if taken in the first 24 hours of an attack. Always follow your physician’s instructions regarding dosing to decrease your risk for potential complications and side effects.

Opioid painkillers, such as codeine, hydrocodone, and oxycodone, are not recommended to treat the pain caused by gout.

3. Apply ice to the joint

Cold therapy can offer significant pain relief by decreasing inflammation and dulling pain signals. If this treatment works for you, you can apply the cold pack intermittently throughout the day for 10 to 20 minutes at a time.

4. Elevate the joint

Propping up the affected joint can ease pressure and reduce pain. If your big toe is affected (about half of all gout cases affect the big toe), prop it up on a pillow or footstool.

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5. Take it easy

Rest the affected joint and keep pressure off it until your pain subsides. Have roomy slippers on hand, so you can keep your feet comfortable until the attack passes.

6. Stay hydrated

Drinking water throughout the day will help flush the uric acid from your system. Aim for drinking 8 glasses a day. Stay away from alcohol and sugary drinks, such as soda and sports drinks, which can make your gout worse.

When medical attention is needed

For severe cases of gout that don’t respond to the treatments above, your physician may recommend corticosteroid injections into the affected joint. Injections can also be useful for people who are sensitive to oral medication.

Prevent gout attacks

You can help prevent a future gout flare-up by avoiding food and drinks high in purines.

Learn more:

1 Ben Salem C, Slim R, Fathallah N, Hmouda H. Drug-induced hyperuricaemia and gout. Rheumatology (Oxford). 2017 May 1;56(5):679-688. doi: 10.1093/rheumatology/kew293
2 Snowden S, Nelson R. The effects of nonsteroidal anti-inflammatory drugs on blood pressure in hypertensive patients. Cardiol Rev. 2011 Jul-Aug;19(4):184-91. doi: 10.1097/CRD.0b013e31821ddcf4
3 Aljadhey H, Tu W, Hansen RA, Blalock SJ, Brater DC, Murray MD. Comparative effects of non-steroidal anti-inflammatory drugs (NSAIDs) on blood pressure in patients with hypertension. BMC Cardiovasc Disord. 2012;12:93. Published 2012 Oct 24. doi:10.1186/1471-2261-12-93
4 InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-. Gout attacks: Pain relief. 2015 Mar 11 [Updated 2018 May 17]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK284948/