Why Should You File a Uloric Lawsuit?
Uloric (febuxostat) is a xanthine oxidase inhibitor for prescription use only. Takeda Pharmaceuticals America Inc. manufactures the drug to be used for treating patients with gout and a related complication, hyperuricemia. But according to a safety announcement from the U.S. Food and Drug Administration, Uloric carries an increased risk of death compared to another medication for gout. Other dangerous Uloric side effects include heart attacks and strokes.
At Parker Waichman LLP, we’re well aware of the very real risks and consequences of taking the gout medicine Uloric. Our experienced product liability attorneys have investigated claims regarding Uloric injuries, particularly after learning this alarming information from the FDA, and we’re here to fight for compensation for victims. If you used Uloric for gout and developed a complication or if your loved one died from Uloric-related injuries, contact Parker Waichman today. We offer free case consultations and can help you understand your legal options.
What Is Gout?
Gout is a condition in which a person has too much uric acid in their body. High retention of this acid can lead to flare-ups around a person’s joints. This condition is characterized by pain, redness, and swelling at the joints.
How Does Uloric Work?
After gaining approval in 2009, Takeda marketed Uloric as the first new option for gout patients in 40 years. The drug is designed to ease gout symptoms by blocking the enzyme xanthine oxidase, which assists in the creation of uric acid. By blocking that enzyme, the drug is supposed to lower a person’s levels of uric acid and relieve gout flare-ups. However, Uloric is linked to numerous safety risks.
What Are the Side Effects of Uloric?
Uloric side effects can range from mild to severe, including:
- Rhabdomyolysis
- Liver failure
- Allergic reactions
- Stevens-Johnson syndrome
- Bone marrow failure
- Heart attack
- Immune system disorders
- Kidney damage
- Nausea
- Psychiatric disorders
- Rash
- Severe bleeding
- Stroke
The FDA reported in its safety announcement in February 2019 that the primary outcome of a safety trial to test for Uloric gout medication side effects was a combination of unstable angina, heart attack, stroke, and cardiovascular-related death. The results showed some tremendously concerning information about the drug:
- For every 1,000 patients treated with Uloric for one year, 15 died from a heart-related complication.
- For every 1,000 patients treated with Uloric for one year, 26 died from other non-heart-related causes.
Uloric and Rhabdomyolysis
Cardiovascular problems aren’t the only risks associated with Uloric. Rhabdomyolysis is one of the most significant adverse reactions associated with Uloric. It’s a potentially fatal condition that involves muscle fiber breakdown that causes the release of the protein myoglobin into the bloodstream. The kidneys may become clogged when they attempt to filter out the myoglobin, which affects the organs’ ability to function normally and can lead to kidney damage. The side effect information for Uloric was updated in January 2011 to include rhabdomyolysis as a potential adverse reaction.
Symptoms can be difficult to identify, as rhabdomyolysis will manifest differently in patients, but they may include:
- Abnormal urine color
- Decreased urine production
- General weakness or fatigue
- Joint pain
- Muscle issues such as stiffness, tenderness, aching or weakness
Uloric and Liver Failure
Liver failure is another of the more serious adverse reactions tied to treatment with Uloric. Increased liver enzyme levels were detected in 4-6 percent of patients taking Uloric. Levels typically returned to normal after Uloric was discontinued. However, around 2 percent of Uloric users experienced increased liver enzymes that were three times greater than the upper limit of the normal level. This represents such a significant increase that full liver failure may quickly follow.
Symptoms of Uloric liver failure may include:
- Abdominal pain or discomfort (upper right side)
- Confusion or disorientation
- Fatigue
- Jaundice (yellowing of the skin and eyes)
- Malaise
- Nausea
- Personality or behavioral changes
- Vomiting
Black Box Warning for Uloric: FDA’s Mixed Messaging
Because testing found that Uloric increased the risk of such severe side effects, the FDA ordered a black box warning for the drug. A black box warning is the most prominent drug warning that can be required by the FDA. When a drug has this kind of warning, it means that a potential complication from the drug can cause extreme injury or death.
The FDA found the gout drug allopurinol to be a safer alternative and went so far as to order that Uloric only be prescribed when a patient doesn’t benefit from using allopurinol or experiences complications while using that drug. Though it’s not unheard of for an individual to pursue an allopurinol lawsuit, the drug is far safer than Uloric, and it’s clear that the FDA took a strong stance against this medication.
However, five months after this edict was issued, the FDA approved an application by Alembic Pharmaceuticals to market febuxostat, the generic form of Uloric. This was followed by a string of similar approvals for other manufacturers looking to sell generic febuxostat. The approvals surprised many, considering the dangers of the brand-name drug and its black box warning.
Frequently Asked Questions
Is Uloric Safe to Take?
By issuing a black box warning, the FDA has essentially concluded that Uloric is unsafe and that alternative medications are far preferable. A doctor will be able to best determine whether this drug is right for you, but it’s important to be aware of the high level of risk associated with the drug.
Is Uloric Safer Than Allopurinol?
Uloric is not safer than allopurinol. In fact, the FDA found allopurinol to be far preferable with fewer risks. Allopurinol is associated with less severe side effects and most commonly linked to the skin condition known as Stevens-Johnson syndrome.
Is Uloric Safe for the Kidneys?
No: Uloric is particularly dangerous to the kidneys. Studies have linked use of Uloric with rhabdomyolysis, which is a severe condition that causes kidney failure. It’s difficult to say if Uloric is more dangerous for the heart or the kidneys, but both are at risk in individuals taking Uloric.
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