Febuxostat entered the gout game in 2009. Before that, allopurinol was the only FDA approved medication to treat gout. Several research studies have concluded febuxostat is the more active drug in lowering uric acid levels. However, it does come with major health risks. The below infographic highlights the effectiveness and risks of febuxostat vs allopurinol.
Febuxostat vs Allopurinol Infographic
[For details on simple ways to lower your uric acid, read: Five Gout-Fighting Condiments That Really Help]
Febuxostat More Effective than Allopurinol
In section 2 of the infograph, the bar graph shows more patients on febuxostat (Uloric) achieved uric acid levels below 6 mg/dL. From the three different studies, the percentages of patients taking febuxostat with safe uric acid levels were: 67% (A), 72% (B) and 74% (C).
The percentage of patients on allopurinol (Zyloprim) were significantly less at: 42% (A), 39% (B) and 36% (C), respectively. These studies confirm febuxostat is more impactful for treating hyperuricemia and gout.
Higher Risk of Death with Febuxostat
Section 4 of the infographic displays results from a long term study causing the greatest concern with the FDA. There were 243 total deaths out of 3098 gout patients taking febuxostat. Compared to patients on allopurinol, the total deaths were less, 199 out of 3092 patients. For fatalities only from heart complications, there were 134 on febuxostat and 100 on allopurinol.
Additionally, the average time frame for a follow up was 2.6 years. The average age of the patients was 65 years (between 44 to 93 years). You can read the complete analysis and evaluation from the clinical trials in the updated Uloric (Febuxostat tablets) product monograph from Takeda Pharmaceuticals.
Based on the clinical trial results, the FDA released a safety announcement stating febuxostat increases the risk of heart-related death, and death from other causes in gout patients. Here is a part of the notice:
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.
Black Box Warning Required for Febuxostat
The FDA black box warning is a distinct black border around the warning or precaution information. You can find the black box on a medication’s label or guide. It emphasizes use of the medication may cause permanent injury or death. Furthermore, it is the FDA’s most serious warning for drugs and medical devices.
The debate over the usefulness of the boxed warning continues to increase. Critics attest the boxed warning may not have any impact to unfamiliar patients and doctors. Also, issues arise regarding what exactly justifies the black box warning.
Final Thoughts
For treating gout, clinical trials conclude Febuxostat (Uloric) is more effective vs allopurinol (Zyloprim). Unfortunately, the major caveat is the higher number of deaths of gout patients especially ones with heart problems. As a result, the FDA warns febuxostat should only be prescribed as the alternative to allopurinol.
From the long term results per cardiovascular deaths, the difference between the two medications was 34 (134 febuxostat, 100 allopurinol). I was surprised the numbers were that high for both medicines.
Febuxostat is considered to be a higher risk, but allopurinol has twice as many major interactions with other drugs. The recurring question is what really makes one medication safer than another? More so, the difference in meanings for the term “less dangerous” and the word “safe”, seem to get lost in translation.
No gout pills necessary, my ultimate goal on being GOUTPROOF.
References
- https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-015-0624-3
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat
- https://www.fda.gov/media/121247/download
- https://www.drugs.com/pro/febuxostat-tablets.html
- https://www.takeda.com/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/uloric/uloric-pm-en.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016084s044lbl.pdf
- https://www.versusarthritis.org/about-arthritis/treatments/drugs/allopurinol/
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