Uloric Liver Warnings Prompt Label Change

Uloric (febuxostat) has given new hope for 3 years to many gout patients who have been unable to tolerate allopurinol.

However, a note of caution is necessary for all gout medications.

Members of GoutPal’s gout support forum have been strong advocates of liver and kidney function testing when on uric acid lowering drugs. This caution is now officially recognized in alterations to Uloric label warnings.

We know that uric acid control is a serious intervention. We also know that failure to control uric acid is a sure way to invite kidney damage, joint destruction, and horrendous disfiguration from gouty tophi. Allopurinol has an excellent safety record, despite high-profile cases of severe, even fatal allopurinol hypersensitivity syndrome (AHS). Uloric removes the risk of AHS, but that does not make it completely safe.

Before I explain new Uloric safety issues, it is important to put this into context. The risks associated with allopurinol are only ever serious when it has been badly prescribed and badly monitored. Uloric is no different.

Most people never have any side effects, and can control their gout. Gout control is vital before it progresses to the point where it cripples you or kills you. However, we have to take responsibility when we take uric acid lowering treatment and make sure we take it safely. Similarly, pharmaceutical companies and doctors have a responsibility to package and prescribe gout medications in the best way to minimize side effects.

The Uloric label has always contained warnings about elevated liver functions. The 2009 version stated:

Laboratory assessment of liver function is recommended at, for example, 2 and 4 months following initiation of ULORIC and periodically thereafter.

One gout forum contributor, the prolific hansinnm, was quick to emphasize the importance of this, and so I strongly recommend that kidney and liver function tests are always included with uric acid blood tests. This is a case of taking maximum care of gout patients, which is unfortunately not the case with some doctors. Monitoring is a vital part of uric acid lowering therapy. This applies to all gout medications, including allopurinol, Uloric, or any other treatment. Good doctoring has now been incorporated into Uloric labeling, with specific instructions to:

  1. Test liver function before starting Uloric
  2. Test liver function whenever patients report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Uloric should be stopped if liver function tests show unsafe ALT.
  3. Avoid Uloric completely if liver function tests show unsafe ALT and bilirubin, as there is a risk of severe liver injury.

Whilst it is good to see that risks are recognized, and early action to minimize risks is recommended, I am disappointed to see that the recommendation for regular liver function test has been dropped. I believe it is wrong for doctors to wait for you to report symptoms before they consider tests. Good doctors will do these tests as a matter of course, but you must be aware. If you are taking Uloric, or allopurinol, insist on regular blood tests for uric acid, kidney function, and liver function.

My other concern is: what constitutes unsafe liver function results? The Uloric label warning is against ALT more than 3 times the reference range and bilirubin more than 2 times the reference range. Given the complete misunderstanding of uric acid ranges in the medical industry, I am very wary of accepting these values. I will investigate this further, and recommend some safe, understandable numbers. In the meantime, if you are on Uloric, and have not had a liver function test, get one today.

Leave Uloric Liver Warnings to browse the febuxostat guidelines

Uloric Liver Warnings Prompt Label Change: Document History
Nov 19, 2012
First Published
Jun 27, 2016
Flagged for review. Review discussion: Improving Uloric Liver Warnings Guidelines for Gout Patients. Vote for this review: Review Uloric Liver Warnings Prompt Label Change.

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