FDA Issues New Black Box Warning for Uloric
The U.S. Food and Drug Administration (FDA) recently announced there is an increased risk of death for people who use Uloric (febuxostat) when compared to allopurinol, another medicine for gout. The FDA reached this conclusion after an in-depth review of results from a clinical trial that revealed there is an increased risk of heart-related death and death from all causes with Uloric.
Due to these findings, the FDA is requiring the prescription information for Uloric be updated to include a “Boxed Warning” also known as a “Black Box Warning” – which is the most prominent warning used by the agency. The FDA is also requiring a new patient Medication Guide for Uloric. The approved use of Uloric is now limited to certain patients who are not treated effectively with or experience severe side effects from allopurinol. It is believed the manufacturer knew of the risks well before they were ordered to implement the Uloric Black Box Warning and new patient medication guide.
Approximately 8.3 million adults in the United States are affected by gout, but unfortunately, there is a limited number of medicines available to treat people with this disease. Uloric was made to treat gout in adults and was approved by the FDA in 2009. Gout develops when uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric is prescribed to lower uric acid levels in the blood.
Consult with a doctor to talk about the benefits and risks of using Uloric to treat gout. Make sure you tell your doctor if you have a history of heart problems or stroke. If you experience any of the following symptoms while taking Uloric, immediately seek medical attention:
- Shortness of breath
- Rapid or irregular heartbeat
- Chest pain
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache
Talk to your doctor to find out whether you should stop taking Uloric. It is important to note that your gout symptoms can get worse if you stop taking Uloric, which is why you should speak to a medical professional about your symptoms.
Uloric Lawsuits Attorneys
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