Colorado Product Liability Attorney
What is Uloric?
Uloric is the brand name for the prescription medication febuxostat. It is manufactured by Takeda, the largest pharmaceutical company in Asia, and is designed to treat gout, a form of arthritis characterized by sudden attacks of pain and joint inflammation.
More than eight million Americans suffer from gout, which is caused by a buildup of uric acid; as the uric acid accumulates, it forms crystals that cause discomfort in joints, leading to redness, swelling, and pain. Uloric relieves symptoms by reducing the amount of uric acid in the body.
When it first received federal approval in 2009, Uloric was hailed as a major breakthrough in the extremely limited field of gout medications and soon became a commonly prescribed remedy for gout patients. However, subsequent studies and emerging evidence of adverse effects have prompted the U.S. Food and Drug Administration to limit the use of Uloric and require new warnings about potentially life-threatening risks associated with the drug.
Uloric Side Effects and Risks
A small number of patients have reported a range of side effects from taking Uloric, including dizziness and nausea. More severe adverse effects have included gout flare-ups, serious skin reactions, and liver damage (sometimes leading to fatal complications).
Even more concerning, though, is the risk of heart-related death associated with Uloric. On February 21, 2019, after reviewing results from a seven-year clinical trial, the FDA required Takeda to produce a “Boxed Warning” (the agency’s most prominent warning) stating that gout patients with a history of cardiovascular disease have a significantly higher rate of death than those treated with another gout medication, allopurinol. The agency also limited the approved use of Uloric to patients who could not tolerate allopurinol.
The FDA urged Uloric patients to seek emergency medical attention immediately if they experienced any of the following symptoms:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache
The issuance of the Boxed Warning has alerted many patients to the heart-related risks associated with Uloric. Some who have suffered heart attacks, strokes, or other serious cardiovascular conditions have become plaintiffs in lawsuits against Takeda.
The Dangerous Drug Attorneys at FDAzar
If you or a loved one has experienced heart-related medical conditions as a result of taking Uloric, you may be entitled to compensation. Please contact the dangerous drug and medical device lawyers at Franklin D. Azar & Associates for a free consultation and no-obligation evaluation of your case.