The FDA has required Uloric (generic: febuxostat), a prescription medication used to treat gout to receive a black box warning. This is the strongest consumer danger warning an item can receive from the FDA. This is due to new information showing that the medication causes an increased risk for severe side effects including kidney damage, heart attack, liver failure, stroke and death.

When the drug was approved in 2009, it was meant to lower uric acid in the blood and reduce sudden attacks of gout. Gout is a type of inflammatory arthritis caused by high levels of uric acid in the blood. Forming needle-like crystals in joints, it causes sudden pain, tenderness, redness, warmth and swelling.

Some watchdog groups warn the black box label does not go far enough and are calling for the product’s immediate removal. As of now, it is approved as second-line therapy for the treatment of hyperuricemia in gout. The FDA is recommending doctors only prescribe Uloric when they see undesirable results with allopurinol, another prescription medication.

The new warning carries information about a potential danger of a patient developing cardiovascular disease because of the medication. Before the research that has come out, many healthcare professionals would recommend Uloric for kidney disease. It seems now, that allupurinol may be a better choice. When it comes to your medication always speak to your physician and follow their recommendations.

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