November 19, 2017 – Gout is a terrible condition for those affected. Gout is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot, and swollen joint. Pain typically comes on rapidly in less than twelve hours. The joint at the base of the big toe is affected in about half of cases. It may also result in tophi, kidney stones, or urate nephropathy. Gout is due to elevated levels of uric acid in the blood. This occurs due to a combination of diet and genetic factors. At high levels, uric acid crystallizes and the crystals deposit in
joints, tendons and surrounding tissues, resulting in an attack of gout. Gout occurs more commonly in those who eat a lot of meat, drink a lot of beer, or are overweight. Diagnosis of gout may be confirmed by seeing the crystals in joint fluid or tophus. Blood uric acid levels may be normal during an attack. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or colchicine improves symptoms. Once the acute attack subsides, levels of uric acid can be lowered via lifestyle changes and in those with frequent attacks, Allopurinol, Probenecd, and Probenecid and Colchicine provide long-term prevention. Taking vitamin C and eating a diet high in low fat dairy products may be preventive.
Besides Allopurinol, Probenecid, and Probenecid and Colchicine, there are newer medications approved for treatment of gout such as Febuxostat (Uloric), approved by the American Food & Drug Administration (FDA) in 2009. Since its approval in 2009, the Febuxostat (Uloric) drug labels already was carrying a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with Febuxostat (Uloric) compared to Allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, the FDA required at the time an additional clinical safety trial (Phase IV- Study) after the drug being approved and on the market to better understand these differences.
According the present Drug Safety Communication by the FDA, this clinical safety study has now conducted in over 6,000 patients with gout treated with either Febuxostat (Uloric) or Allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, Febuxostat (Uloric) did not increase the risk of these combined events compared to Allopurinol. However, when the outcomes were evaluated separately, Febuxostat (Uloric) showed an increased risk of “heart-related deaths” and “death from all causes“.
These findings are of serious nature. Consequently, FDA urges health care professionals and patients to seriously consider this safety information when deciding whether to prescribe or continue patients on Febuxostat (Uloric). Patients should talk to their health care professionals if they have any questions or concerns. They should not stop taking their medicine without first consulting with their health care professional. FDA also urges health care professionals and patients to report side effects involving Febuxostat (Uloric), or any other medication for that matter, to the FDA MedWatch program online.
Ph.D.; Professor in Pharmacology and Toxicology.
Senior expert in theragenomic and personalized medicine and individualized drug safety.
Senior expert in pharmaco- and toxicogenetics.
Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
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