Uloric Side Effects: Don’t Be Broken-Hearted

There is a new report about Uloric side effects. It is more of a review than an investigation, but before I summarize it I would like to repeat my views on side effects.

Most medicines produce effects in humans that are additional to the intended benefits. Doctors accept this, and have to deal with it. Patients have to learn to deal with it too. The trick to dealing with side effects is to take a balanced view.

The only time you should stop taking any medicine is when the unwanted effects are worse than the benefits of the treatment. So, to judge any uric acid lowering medication, you have to understand the risks of not treating it.

These are severe. Gout is much more than a few painful joints. Gout spreads eventually to all joints, and whilst modern pain relief means you never have to lose mobility, long term pain relief is rarely safe. The main pain relief for gout is colchicine and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Both these are unsuitable for long-term use. I’ve written before about breathing problems associated with longterm colchicine use. Cardiovascular risks of longterm NSAIDs are well known, and feature prominently as warnings on all NSAIDs labels. We can reduce these risks considerably by lowering uric acid to safe levels, which ensures that we will stop gout attacks in future.

One further piece of relevant background information before I summarize the Uloric side effects report. Most gout patients who take Uloric, do so because they are intolerant to allopurinol. It is therefore likely that such patients have had to take pain relief for many years, as there was no real alternative to allopurinol.

Uloric Side Effects Report

This is my layman’s summary of the published abstract for:

Title:
Cardiovascular thromboembolic events associated with febuxostat: Investigation of cases from the FDA adverse event reporting system database
Authors:
Gandhi PK, Gentry WM, Bottorff MB.
Published:
Semin Arthritis Rheum. 2013 Jan 24.

Cardiovascular means pertaining to the heart and blood vessels. Thromboembolic means pertaining to a closure or blockage of a blood vessel caused by particles that break away from blood clots. Cardiovascular thromboembolic events (TCEs) are heart attacks, unstable angina, and stroke caused by loose particles from blood clots.
Febuxostat is the generic name for the Uloric brand

Uloric Side Effects Report Objective

Uloric (febuxostat) has been linked with cardiovascular thromboembolic events in gout patients. However, no post-marketing data analysis has investigated these drug-associated adverse event reports. The study objective was to identify febuxostat-associated cardiovascular thromboembolic event reports in the US using the Food and Drug Administration adverse event reporting system database.

Uloric Side Effects Report Methods

Reports were extracted from the drug’s approval date through the fourth quarter of 2011. The study extracted adverse events where:

  1. Uloric and febuxostat were the suspect drug
  2. and

  3. cardiovascular thromboembolic events were the adverse event

These extracts were analyzed using recognized statistical methods. These methods produce a potential signal when there is a statistical chance that drug and event are related.

Uloric Side Effects Report Results

21 relevant events were identified in gout patients in the US, with an average age of 64. The statistical analysis produced a potential link between Uloric and cardiovascular thromboembolic events.

Uloric Side Effects Report Conclusions

The adverse event reporting system indicates a link between Uloric and heart disease, angina, stroke and similar side effects. The use of statistics rules out the ability to determine if there is a direct cause and effect link. The potential link merits further monitoring and investigation.

Uloric Side Effects Report: GoutPal View

It strikes me that, whilst it is right to raise concerns if there are real health risks, it is pointless to do so without a better profile of the patients who have had heart problems.

Logic dictates that it is very likely that Uloric patients have been exposed to longterm NSAIDs, which carry well known cardiovascular risks. Therefore it would be expected that a higher than average proportion of Uloric patients would suffer these side effects. Until we get proper investigation which consider patients history on a case-by-case basis, we will never know if there are any real risks involved.

Uloric Side Effects: Next Steps

If you are worried about Uloric side effects, you must discuss your concerns with your doctor. Please share your doctor’s advice in the gout forum.

Leave Uloric Side Effects Report to see the Uloric Side Effects guidelines.

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