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FDA Requires Black Box Warning to be Added to Uloric

As reported online in a news article from thepharmaletter.com, the U.S. Food and Drug Administration has ordered a Black Box warning to be placed on a popular drug prescribed for gout. The warning is associated with newly surfaced information indicating that the drug Uloric is associated with an increased risk of death. For several months, […]

Fda requires black box warning to be added to uloric

Gout condition in toe

As reported online in a news article from thepharmaletter.com, the U.S. Food and Drug Administration has ordered a Black Box warning to be placed on a popular drug prescribed for gout. The warning is associated with newly surfaced information indicating that the drug Uloric is associated with an increased risk of death.

For several months, the FDA has been conducting an investigation into the safety risks of the gout drug Uloric (febuxostat). This investigation is now closing with the requirement that the manufacturer place a strong boxed warning on the drug label. The FDA is also implementing a requirement that use of the drug be limited only to patients who have not received therapeutic benefit from another gout drug called Zyloprim (allopurinol).

The Black Box warning for the drug Uloric and its generic counterpart will need to include information stating that the drug is linked to increased risk of death from cardiovascular problems and increased risk of death from all other causes. The FDA has also ordered a new patient guide for the drug that outlines the updated risks and benefits of taking the medication.

Uloric has been on the market since 2009 when it was approved for treatment of gout and the symptoms of gout. The manufacturer of the drug is Takeda Pharmaceuticals. From the point of approval, the drug label for Uloric has stated the medication is linked to increased risk of gout flares and to cardiovascular events, as well as hepatic toxicity and dermatological complications.

Upon receipt of information gathered in a post-market study on Uloric, the advisory panel of the FDA convened in January 2019 to discuss the health risks of the drug and whether the drug should be pulled from the market. The panel voted at that time to maintain the drug’s availability, finding that the benefits still outweighed the potential health complications to patients. However, the majority of the panel also agreed that Uloric should be used as a backup for most patients who have gout.

Takeda will now have to update its drug label for Uloric to reflect the requirements from the FDA and will need to generate a new Medication Guide for patients to review when their doctors prescribe Uloric. Updates to the generic version of the drug will then follow. For more information about recovering compensation, please read our Uloric Gout Treatment Side Effects Causes Heart Attacks and Death Lawsuit page.

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