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

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fda.gov/Drugs/DrugSafety/uc...

"...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...."

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katieoxo60

Thank you for info, I had strange side effects with Allopurinol the doctor felt the problem would be similar or worse with Uloric, so we settled for no drug except in flare up. Are any other drugs being tested at present? I had to stop my blood pressure tablets too as they were raising the uric acid due to long term use. I am sure a lot of my stiffness and pain is due to the gout and the only option seems to be diet control.

Dmactds profile image
Dmactds in reply to katieoxo60

Diet/Self control seems to be the solution to many things: I just found that in addition to emphysema, secondary erythrocytosis and other usual aches and pains of 'older' age, I can look forward to 'enjoying' dealing with pre-diabetes for the next few years until I finally croak from too much 'happiness' during these, my golden years. After investigating what I'd have to start/stop eating to deal with my 'glucosian ailment' I've decided it amounts to little more than avoiding those things which are bad for you and that you should've been avoiding all these years anyway.

As one final swat at my psychi, I seem to have worked out that the reason for the rash and resulting small sores on my legs is the polyester in the long johns I've been wearing this winter. Never in my life have I worn something so 'binding' and never have I worn polyester, at least so close to my body.

Yes..., when all is said and done, it really is up to us and us alone to keep our respective boats in the middle of the road.

katieoxo60 profile image
katieoxo60 in reply to Dmactds

You are right it is a bit about doing whats best for yourself, I have a rash on my legs which seems to get bigger and bigger. Maybe like you its the material in my trousers thanks for tip. It does not itch just a red patch on both legs in the shin area.Just got a letter from the pain clinic which totally contradicts itself. This is the second time this clinic result as sent out a letter that does not tally. This is three visits now to no avail. So all we can do is plod on.Enjoy this sun while its around have a relaxed weekend.