Uloric is a drug used to treat chronic gout.
Unfortunately, this dangerous drug can also lead to an increased risk of cardiovascular-related death when compared to other gout medications.
Individuals who took Uloric may be eligible for money to compensate for complications associated with the drug.
If you or a loved one has been injured or died as a result of taking Uloric, VanDerGinst Law can get you the compensation you deserve.
Contact the experienced attorneys at VanDerGinst Law today.
What is Uloric?
Uloric, or Febuxostat, is a drug manufactured by Takeda Pharmaceuticals USA, Inc. It is used for the treatment of chronic gout, which is a type of arthritis caused by a buildup of Uric acid.
Gout causes inflammation, swelling, and destruction of cartilage and bone. It can be a debilitating condition.
Uloric is the second best-selling medication for gout currently on the market and has over 1 million prescriptions in the US market.
It entered the market in 2009 claiming to treat chronic gout with the only possible side effects being gout flares, joint pain, nausea, mild rash, and liver problems.
In initial trials, the effectiveness was shown to be slightly better than Allopurinol, its competitor, but it had significantly more risks.
Uloric Pharmaceutical Studies
It’s important to note that Takeda Pharmaceuticals had to try three times to get approval from the U.S. Food and Drug Administration (FDA) before it was placed on the market.
In December 2004, they were denied due to higher risks and no apparent clinical benefit.
The same happened in December 2006 when the FDA expressed concerns with the clinical method, collection of data, and lack of general details.
On the third attempt, the drug was sent to an advisory committee which gave approval but required Takeda to conduct a Phase 4 Post-Market study.
In a Phase 4 Post-Market Study, the study is conducted after the drug is already on the market.
This study involved about 6,000 participants and compared Uloric to generics and other brands on the market.
The results showed no significant difference in gout flare-ups, and there were significantly higher (34% higher than Allopurinol) instances of cardiovascular deaths.
Additionally, this study was conducted by the manufacturer of Uloric, which means it would place Uloric in the best light possible.
Known Side Effects of Uloric:
- Heart attack
- Liver failure
- Heart-related death
Black Box Warning February 2019
A black box warning is the most severe warning put on a drug.
In February 2019, a black box warning was issued by the FDA for Uloric due to a 40-50% increased risk of cardiovascular death in comparison with Allopurinol.
Takeda Pharmaceuticals failed to adequately warn consumers of the higher risk of death over Allopurinol and failed to advise that it only slightly improved the rate of lowering uric acid.
It’s important to note that it is also significantly more expensive.
Have you been affected by Uloric?
Knowing if you have a Uloric lawsuit on your hands can be difficult to understand without an experienced attorney.
If you or a loved one has experienced adverse cardiovascular events, stroke, heart attack, liver failure, death, or other similar symptoms, you may be entitled to compensation.
Contact us today for a free consultation. Call now 800-797-5391.