Hyperuricemia refers to the medical term indicating high blood uric acid levels in the body. Due to the condition, you can develop several conditions, including a specific type of painful arthritis known as gout. To treat gout, doctors prescribe Uloric (Febuxostat) to patients. It is prescribed when another common medication allopurinol does not offer relief. Unfortunately, the use of Uloric increases the risk of death in people. FDA (Food and Drug Administration) in the US studies in detail the results of the clinical trial, which indicated the increased risk of heart-related death in people using Uloric.
As a result of the findings, the FDA has updated the prescribing information of Uloric. So, it now comes with a Boxed Warning (the most prominent warning issued) along with a new Medication Guide. So, doctors are now limiting the approved use of the medication to specific patients who experience severe side effects or do not get effective relief with allopurinol.
What Is Uloric?
In 2009, the FDA approved Uloric as one of the medications to treat gout, a type of arthritis in adults. Gout is the condition developing when the uric acid increases to high levels. Uric acid is a naturally occurring substance and high levels of it can lead to swelling, redness, and pain in one or more of your joints. Gout is a chronic disease that affected a large number of population. So, using Uloric lowers the uric acid levels and alleviating the symptoms associated with the condition. Uloric is only one of the few medications treating the condition. Due to the limited medication available to manage the condition, there remains an unmet need to treat the disease.
Warning While Taking Uloric
Patients having a history of heart problems or stroke need to consult their healthcare professional regarding the benefits and risk of using Uloric. Seek immediate medical help when you experience the following:
- Shortness of breath
- Chest pain
- Irregular or rapid heartbeat
- Severe headache
- Trouble talking
When you see the symptoms indicated above, it needs immediate medical attention. Never stop the medication without consulting the doctor as it can do more harm. Stopping the medication can lead to worsening of gout.
Studies Indicating Severity OfUloric
FDA approved Uloric with a Warning and Precaution in 2009. The warning indicated the possibility of suffering from cardiovascular disease in patients treated with Uloric. The safety clinical trial conducted on more than six thousand patients suffering from gout offered the result. But, patients received either Uloric or allopurinol to treat gout. The outcome indicated heart-related death, non-deadly stroke, non-deadly heart attack, and unstable angina. As the overall results indicating Uloric does not increase the risk compared to allopurinol, The FDA approved the medication.
But, during the evaluation of the results separately, Uloric showed an increased risk of heart-related complications and death due to the complication. The staggering observation of fifteen death in a thousand people treated with the medication in a year has resulted in rethinking about the medication. So, doctors have now limited prescribing Uloric to people who cannot tolerate allopurinol and show no improvement in their symptoms.
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