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

Κατηγορίες: Επιστημονική Ενημέρωση

FDA Drug Safety Communication – Safety Announcement

The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Adenuric (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 Adenuric.

As a result, we are updating the Adenuric 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 Adenuric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

Adenuric 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. Adenuric 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 Adenuric to treat your gout. Seek emergency medical attention right away if you experience the following symptoms while taking Adenuric:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

Do not stop taking Adenuric without first talking to your health care professional, as doing so can worsen your gout.
Health care professionals should reserve Adenuric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Adenuric and advise them to seek medical attention immediately if they experience the symptoms listed above.

When we approved Adenuric in 2009, we included a Warning and Precaution regarding possible cardiovascular events in patients treated with Adenuric 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 Adenuric 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, Adenuric did not increase the risk of these combined events compared to allopurinol (See Data Summary). However, when the outcomes were evaluated separately, Adenuric showed an increased risk of heart-related deaths and death from all causes. In patients treated with Adenuric , 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 Adenuric 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.

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

This is an update to the FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric) issued on November 15, 2017.

Released 2-21-2019.