What is Uloric?
Uloric (febuxostat) is a prescription medication used to treat patients with gout which is caused by hyperuricemia, a condition that creates high uric acid in the bloodstream. Manufactured by Takeda Pharmaceuticals and introduced to the market with FDA approval in February 2009, Uloric was intended as an alternative to treating gout with Zyloprim (allopurinol). When the Food and Drug Administration (FDA) approved Uloric in 2009, the FDA was concerned Uloric could be dangerous and could cause cardiovascular conditions, so it required that Takeda conduct a mandatory post-marketing cardiovascular safety study.
The results of the 6,000-patient safety study trial were published in the New England Journal of Medicine on March 29, 2018. The authors of the study found a statistically significant increased risk of cardiovascular death for users of Uloric compared to users of allopurinol.
Gout is a form of arthritis materializing as sudden, severe pain, redness, joint tenderness and swelling. Gout is often found in lower joints like the ankles, feet and toes, but it can also appear in the hands, wrists, and fingers. Gout is caused by elevated uric acid levels in the blood.
Gout can be very painful and debilitating. There are only a few medicines on the market to treat gout. The drug allopurinol has long been the go to medication to treat gout. Allopurinol has an established safety profile and has been available as a generic medication since 1984. Only patients with severe kidney dysfunction, or those who's body cannot process allopurinol, would be taking Uloric. Allopurinol is an effective gout medication, with a history of use without severe side effects and it is also much cheaper than Uloric.
What Do We Know About Hyperuricemia and Gout?
Hyperuricemia is a condition that leads to too high of levels of uric acid in the body which can cause gout. Normally, uric acid is removed through urination. But, in individuals with hyperuricemia, excess uric acid remains which can cause urate crystals which then build up in joints, fluids, and tissues in the body. Hyperuricemia does not always cause gout, and without gout symptoms, the condition does not need to be treated. But, if symptoms such as intense pain, swelling, redness, or heat arise, immediately seek medical attention.
More than 8.3 million Americans suffer from gout. Gout is a form of inflammatory arthritis that can cause extreme discomfort and pain. It is very common for an individual to go between phases of flare-ups and remission. Uloric is one of the medications used to treat gout and it works by blocking the metabolic processes in the body that create uric acid. The blocking mechanism helps to prevent a build up of urate crystals which trigger gout.
However, a link between Uloric and cardiovascular events, including sudden death, has been discovered prompting lawyers to look into a Uloric lawsuit.
It is highly recommended that only those individuals with severe renal dysfunction or those who cannot take Zyloprim (allopurinol) be prescribed Uloric because of the safety concerns.
Postmarket Safety Clinical Trial Raises Question of Safety
Uloric was approved in 2009, yet the approval only came after two failed attempts at approval in 2005 and 2006. As a condition of approval and introduction to the market, the FDA required Takeda to conduct a postmarket safety clinical trial because of the continued questions and concerns surrounding Uloric.
As a result of preliminary results from the trial, the FDA issued a drug safety communication because of concerns of safety. The results of that trial showed an increased risk of heart-related death. During the trial, 6,000 individuals suffering from gout were treated with either Uloric or allopurinol. Those taking Uloric were found to have a higher rate of “heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery” compared to those taking the other gout medication.
In 2018, the FDA received the full trial report which, after months of in-depth reviews, prompted the FDA to issue an updated safety warning which included a black box warning, the most severe warning that can be issued. However, the FDA did not take the medication off the market which raised further concerns from individuals and doctors alike.
Based on existing Uloric lawsuits and according the FDA’s website, patients with gout taking Uloric should seek emergency medical attention if they experience any of the following symptoms:
These symptoms are all risks signs that could result in a more serious injury or situation. Because Uloric could potentially cause the following issues, it is vital that you seek emergency medical attention right away if you experience one or more of the above symptoms. Patients taking Uloric may face an increased risk of:
Our product liability attorneys are available to assist people who suffered a heart attack, stroke or death while taking Uloric medication to treat their gout. These lawsuits are not against the doctors who prescribed Uloric, but instead are product liability lawsuits against Takeda Pharmaceuticals. The Takeda lawsuits are centered on a “failure to warn” claim because Takeda failed to warn the people taking Uloric of the increased risk of heart attacks and strokes shown to be caused by the medication. Contact us 24/7/365 at 1-800-856-6405.