Since the FDA added a boxed warning to Uloric for elevated risk of fatal cardiovascular events in February 2019, physicians and patients who take Uloric for gout are reconsidering the treatment. Because of the possibility of death, Uloric has since been removed as a first line treatment for gout. Heart-related deaths among Uloric patients run 1.5 percent. Deaths from all causes among Uloric patients are 2.6 percent.
What alternative medications are currently available?
First of all, it should be understood that Uloric (febuxostat) has been used primarily in patients who are unable to tolerate, or fail to respond to allopurinol. Sold under the brand names Zyloprim and Aloprim, allopurinol is a prescription drug used for the reduction of uric acid in general. Elevated uric acid is a cause of gout, and can be the result of a diet high in saturated fat; however, it can also be caused by tumor lysis syndrome, a complication associated with some cancer treatments in which large numbers of cancer cells are killed off all at once, spilling their wastes into the bloodstream.
Uloric has been shown to have greater efficacy than allopurinol at standard dosage, but not at higher doses. First approved in 1966, allopurinol is available in generic form and is taken by approximately 15 million patients in the U.S. The risk of death from taking allopurinol is lower than that of Uloric (1.1 percent attributable to cardiac events and 2.2 percent from all causes). Because it is excreted through urination, it can be prescribed for those suffering from impaired kidney function. It is also inexpensive, costing less than $1 a day.
On the other hand, dosing can be complicated. Although it has been and is once more the primary treatment for high uric acid levels in patients with kidney disease, it can cause a rare, but potentially fatal condition known as allopurinol hypersensitivity syndrome (AHS). This is of particular concern with patients who suffer from impaired renal function. AHS is characterized by fever and skin rash, and can lead to even more serious conditions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis. Allopurinol is also liked to bone marrow problems that can negatively affect blood cells, and kidney inflammation. There are also many drug interactions; patients taking allopurinol require constant monitoring.
Another prescription medication used to treat gout is colchicine, which is a non-steroidal anti-inflammatory drug (NSAID). It is derived from the autumn crocus, or meadow saffron plant, used for some 3500 years to relieve joint swelling. Available in generic form, colchicine is nonetheless quite expensive compared to allopurinol (over $250 a month in the U.S., largely due to the price gouging that has been endemic in recent years). At moderate doses, colchicine’s primary side effects are relatively minor, consisting of gastrointestinal upset and diarrhea; compromised immune function is also a known risk factor. However, an overdose of colchicine can be fatal.
There are no simple answers for gout sufferers, since all treatments entail some level of risk. If you have been taking Uloric for gout and have concerns, the best course of action is to discuss those concerns with your primary care physician.