A Uloric FDA alert has been issued, warning consumers that preliminary study results show an increased risk of heart-related death with the drug.

In November 2017, the U.S. Food and Drug Administration (FDA) issued a Uloric FDA alert. The safety communication alerted consumers and physicians that preliminary results from a clinical trial showed an increased risk of heart-related death in patients taking Uloric.

Uloric’s label already carried a warning about cardiovascular events related to the drug, due to the results of clinical trials before the drug’s release. According to the Uloric FDA alert, the safety trial was ordered by the FDA after clinical trials showed a higher risk of heart-related problems in patients treated with Uloric when compared to patients treated with similar medications.

Cardiovascular events reported during the initial clinical trials include heart attacks, strokes, and heart-related deaths. Depending on the results of the safety trial, additional warning or action may be required.

The safety trial studied over 6,000 patients with gout treated with either Uloric or a similar medication. The results involve a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart.

“Preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol,” the Uloric FDA alert states. “However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes”.

The FDA encourages healthcare professionals to consider the risk associated with Uloric when prescribing the medication to patients with gout. Once the final results of the study are received, the FDA will conduct a review and update the public again in a new Uloric FDA alert.

Gout is a form of arthritis which involves a buildup of uric acid crystals in the joints. In typical patients, uric acid dissolves in blood and passed through the kidneys into the urine. In patients with gout, the body either produces too much uric acid or the kidneys don’t process enough uric acid out of the body. When uric acid builds up in the joints, it can form sharp, needle-like crystals which irritate tissues. Symptoms of gout include intense joint pain, lingering discomfort, inflammation, redness, and limited range of motion.

Many patients treat gout flare-ups with lifestyle changes such as avoiding certain foods or losing weight. However, not all patients are able to manage their gout through lifestyle methods and turn to medication to manage the condition. Uloric (febuxostat) is a medication used to treat gout in patients.

The drug works by limiting the amount of uric acid made in the body, preventing the buildup of uric acid in the patients’ body. Uloric was developed as an alternative to allopurinol, a popular gout medication, which reportedly causes kidney problems and severe allergic reactions.

If you or a loved one developed cardiac side effects after taking Uloric, you may qualify for a Uloric lawsuit. A Uloric lawsuit could help recover compensation for medical expenses, loss of wages, pain and suffering, wrongful death, and more. Fill out the form on this page to request a free case evaluation.