The US Food and Drug Administration (FDA) reported on February 2, 2109, that it had reached the conclusion that “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” The FDA reached the conclusion due to a safety clinical trial which “found an increased risk of heart-related death and death from all causes with Uloric.” The FDA now is requiring that the manufacturer provide a “Boxed Warning,” and a new medication guide. The FDA announced it is limiting the approved use of Uloric to patients who have severe side effects or aren’t responding to allopurinol.
Uloric was first approved by the FDA in 2009 to treat gout, a form of arthritis, in adults. Gout is caused by uric acid build up in the body, which causes “sudden attacks of redness, swelling, and pain in one or more joints.” Uloric helps to reduce the levels of the uric acid in the blood. Gout affects more than eight million Americans. There are currently limited drugs and treatments for gout.
Some of the possible dangers in using Uloric, according to the FDA, include:
- “Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache”
The FDA recommends that patients who are using Uloric speak with their doctor before discontinuing usage. The original approval by the FDA required that the company, Takeda Pharmaceuticals, that made Uloric include a “Warning and Precaution” regarding possible heart risks.
Anyone who is suffering from using Uloric may have a product liability claim. Families may have the right to file a wrongful death claim on the decedent’s behalf.
A clinical study led the FDA to conclude Uloric is dangerous
The clinical trial studied more than 6,000 patients with gout and their responses to Uloric or allopurinol. The trial found that:
“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year. In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”
Gout is normally analyzed through:
- Blood tests
- A test of the fluid joint
- X-rays and ultrasounds
Some of the treatments for the pain of gout in addition to allopurinol and Uloric include Nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and prednisone.
Patients and families of loved ones who are harmed by Uloric may have the right to file a product liability claim against the manufacturer. Drugs are subject to product liability claims if they are defective and the defect causes injuries or deaths. The FDA conclusions are strong confirmation that Uloric is defective. To learn if you have a product liability claim, give Mezrano Law Firm a call today at 205.407.1768 or use our contact form to schedule an appointment. We represent seniors and families who live in or near Birmingham, Tuscaloosa, Mobile, Montgomery, Florence, and Gadsden.