May 04, 2019 - The FDA recently released a drug afety communication for Uloric, a gout medication manufactured by Takeda Pharmaceuticals. Prior to this safety communication, the FDA had notified the public they were evaluating Uloric for possible connections to an increase risk of heart-related deaths. After a more thorough investigation, the FDA determined Uloric increased the risk of death from all causes. The FDA has also required that Takeda add a high-level "black-boxed" warning to the label of Uloric to ensure physicians and consumers are aware of the potential dangers of the drug.
Gout is a form of arthritis which can result in sudden, severe attacks of tenderness, pain and swelling—in many cases in the big toe area. Gout attacks tend to come and go, often causing excruciating pain when flare-ups occur. Urate crystals accumulate in the affected joint, causing inflammation and pain; when the body breaks down, purines found in certain foods and in the body, uric acid is produced. For most people, the uric acid will dissolve as it is processed by the kidneys, however certain factors may cause the uric acid levels to build, creating crystals and causing gout.
Factors associated with gout include a family history of the disease, being overweight, diet, trauma, and certain medical conditions such as cancer, cardiovascular disease, sleep apnea, diabetes and kidney disease/kidney stones. Uloric gained FDA approval in 2009—the drug works by lowering uric acid levels in the blood, and even though it was approved, the FDA did have reservations. Takeda was required to conduct a large clinical Uloric trial as a condition of the drug’s approval since cardiovascular issues had already been associated with the drug.
The data from the 6,000 person Uloric trial led the FDA to require Takeda to add a more serious black box warning on the drug. Not only did the clinical trial point to an increase in cardiovascular deaths among those taking Uloric, it showed a strong correlation between those taking Uloric and an increase in death from all causes. Among patients treated with Uloric there were 15 deaths for each 1,000 patients from cardiovascular-related issues. More alarming, there were 26 deaths from any cause per 1,000 patients treated with Uloric. Current recommendations from the FDA are that Uloric only be prescribed to patients who have not had positive results with the “other” gout drug, Allopurinol. When doctors do choose to prescribe Uloric, the FDA has warned that these patients should be monitored carefully for signs or symptoms of cardiovascular issues. These symptoms could include:
- Headache with a sudden onset;
- Chest pain;
- Rapid heartbeat;
- Numbness or weakness on one side of the body;
- Dizziness, and
- Shortness of breath.
Takeda faced a whistleblower lawsuit earlier which was filed by a former safety consultant for the company, Dr. Helen G. Ge claimed that the company was aware of safety risks associated with Uloric yet downplayed those risks in order to continue to sell the drug. Those who have suffered a heart attack or other injury as a result of taking Uloric could potentially benefit from speaking to an experienced Uloric lawyer to discuss potential options. The Personal Injury Lawyers at Sullo & Sullo are currently evaluating Uloric Injury Claims for potential future litigation.