Patients with dual conditions that include heart disease and gout, a type of arthritis characterized by an elevation of uric acid in the blood, are more likely to die as a result of Uloric side effects, studies report.
Uloric, also known generically as febuxostat, is a medicine used to treat the arthritic condition which usually painfully affects one or two joints where uric acid forms crystalline deposits.
The author of the study, Dr. William White of the University of Connecticut School of Medicine, was surprised by the results of his long-term study of Uloric side effects and lacks an easy explanation for the data generated. According to a Reuters article, the CARES study was undertaken to compare the cardiovascular Uloric side effects with those from Allopurinol, another U.S. Food and Drug Administration (FDA)-approved treatment for gout.
In 2009, the FDA necessitated that Uloric’s manufacturer Takeda Pharmaceuticals conduct the CARES study as a condition of market approval. The reason for this was data generated during clinical safety trials that among Uloric side effects was an increase in non-fatal cardiovascular problems and risks.
The results of the study were both presented in March in Orlando, Fla. at an annual meeting of the American College of Cardiology and published online in the New England Journal of Medicine.
Participants in the CARES study all had symptoms of or a history of heart disease and were diagnosed with gout. There were initially 6,190 enrollees and about 3,100 stayed active with the study for at least two years and eight months.
Half of the participants took allopurinol and the other half took Uloric. Dr. White indicated that this break-down doesn’t reflect how the medications are prescribed in actuality. While there are 8 million citizens that suffer from this specific type of arthritis, only 7.5 percent are prescribed febuxostat with physicians overwhelmingly favoring allopurinol for treatment.
This preference may have something to do with cost in that febuxostat is almost twice as expensive, putting it out of reach of many gout patients. As the Reuters article suggested, Dr. White thinks that the Uloric side effects data will probably cause some further prescriptive hesitation in physicians.
The CARES Data
The Cares study revealed that the risk of dying from Uloric side effects of a cardiovascular nature was 34 percent higher in participants with preexisting heart disease. This was as compared to those taking Allopurinol which has been in use since 1966. Sudden death from any cause was 22 percent higher in those taking Uloric that Allopurinol.
It is important to note that gout-suffers already have a higher risk of cardiovascular and kidney disease. Allopurinol has been linked to a higher risk of developing kidney problems, particularly if the patient is of African-American descent.
If you or a loved one have taken Uloric and suffered cardiovascular side effects, you may have a legal claim that a knowledgeable pharmaceutical products attorney could help you with.
In general, Uloric lawsuits are filed individually by each plaintiff and are not class actions.
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