On Feb. 21, 2019, the U.S. Food and Drug Administration (FDA) announced that it was updating the prescribing information for Uloric (febuxostat), a gout medication, to include a Boxed Warning due to the drug’s link to an increased risk of heart-related deaths and deaths of all causes.
Because of the risks associated with Uloric, the FDA will limit its approval for the treatment of gout-suffering patients who respond poorly to or experience severe side effects with allopurinol, another gout medication.
The FDA urges patients who experience any of the following symptoms to contact their doctors right away:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of the body
- Dizziness
- Trouble talking
- Sudden severe headache
However, the FDA also cautions patients to not stop taking the medication without first talking to their doctors, as sudden cessation can result in a worsening of gout symptoms.
The FDA decided to require a Boxed Warning for Uloric after analyzing the results of a safety clinical trial completed by the drug’s manufacturer Takeda Pharmaceuticals. The study found that patients taking Uloric had a higher risk of heart-related deaths and deaths of all causes compared to patients taking allopurinol.
If you or someone you love took Uloric and suffered a heart-related injury or adverse health effects, the drug injury lawyers at Ferrer Poirot Feller Daniel want to speak with you. Contact us today for a free consultation.