FDA Orders Uloric Black Box Warning for Increased Risk of Death
According to a Safety Announcement from the U.S. Food and Drug Administration, the drug Uloric (generically known as febuxostat) carries an increased risk of death compared to another medication for gout. This includes an increased risk of death from cardiovascular events and from all other causes.
Parker Waichman LLP knows that you and your family members are dealing with the real consequences of Uloric injuries. Our experienced product liability attorneys have been investigating claims regarding Uloric injuries, and we will fight for compensation for victims, particularly after learning this alarming information from the FDA.
If you used Uloric for gout and developed a complication, or if your loved one died from Uloric-related injuries, contact Parker Waichman LLP today. We offer free case consultations and can help you understand your legal options, because Uloric Gout Treatment Side Effects Causes Heart Attacks and Death Lawsuit.
Uloric is Indicated for Treatment of Gout
Uloric (febuxostat) is a xanthine oxidase inhibitor for prescription-use only. Takeda Pharmaceuticals America Inc. is the manufacturer of the drug. Doctors treating patients with gout and the complication hyperuricemia might prescribe Uloric for those conditions.
Gout is a condition in which a person has too much uric acid in his or her body. High retention of this acid can lead to flareups around a person’s joints. This is characterized by pain, redness, and swelling at the joints.
Gaining approval in 2009, Takeda marketed Uloric as the first new option for gout patients in 40 years. The drug is designed to help gout symptoms by blocking the xanthine oxidase enzyme, 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 flareups. However, Uloric is linked to numerous safety risks.
Uloric Injuries and the CARES Trial: Increased Risk of Cardiovascular Events and Death
When the FDA approved Uloric for market in 2009, it required information to be placed in the Warnings and Precautions section of the drug label regarding cardiovascular events. The warning states that a higher rate of cardiovascular thromboembolic events was seen in patients who were taking Uloric in a controlled study versus another gout drug, allopurinol. This includes events like cardiovascular death, stroke, and myocardial infarction.
Because of concerning information that surfaced during controlled studies, the FDA ordered Takeda to perform a larger post-market study to assess the potential health risks of the drug. This study, called the CARES trial, was ongoing for some time after the drug was first approved. It included 6,000 people who were taking Uloric or allopurinol.
The FDA reported in its Safety Announcement of February 2019 that the primary outcome of the trial was a combination of unstable angina, heart attack, stroke, and cardiovascular-related death. The FDA said the trial results indicated the Uloric caused these conditions at the same rate as allopurinol, but the agency went on to say that Uloric was associated with an increased risk of death from cardiovascular events and from ALL causes.
The information gained from the CARES trial prompted the FDA to mandate a Black Box warning for the drug Uloric and to limit the drug’s use in patients.
FDA Mandates Black Box Warning for Uloric, Limits Use of Drug
In its announcement of February 2019, the FDA stated that it was ordering a Black Box warning for the drug Uloric. 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 results from the Uloric CARES trial, according to the FDA, 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; and
- For every 1,000 patients treated with Uloric for one year, 26 died from other non-heart-related causes.
Based on these results, the FDA concluded that Uloric is linked to an increased risk of death, both from cardiovascular complications and from all other causes. This moved the FDA to action and prompted the required Black Box warning.
In addition, the FDA indicated in its Safety Announcement that it was requiring Takeda to produce a new patient Medication Guide that explained the serious risks associated with taking Uloric. Moreover, in a step rarely taken by the agency, the FDA also stated it would limit the use of Uloric to just those patients who did not receive benefit from allopurinol or who experienced side effects of allopurinol.
In other words, the FDA is saying that patients should always start with the safer option, allopurinol, and only move on to Uloric, which has higher risks, if they do not achieve relief from other treatments. Few drugs receive this kind of limitation from the FDA, and when it happens, it means the drug has the dangerous potential to harm consumers.
FDA Approves Generic Gout Medication That May Be Dangerous to Patients
(07/25/2019) UNKNOWN – The United States’ Food and Drug Administration recently gave a nod of approval to Alembic Pharmaceuticals’ febuxostat tablets, a generic form of the drug Uloric (manufactured by Takeda Pharmaceuticals) that is used to treat gout. The approval of febuxostat is surprising to some, considering that Uloric sports a warning from the FDA advising consumers and doctors that the drug carries with it an increased risk of death. The risk is considered so significant that Uloric itself is no longer the first drug of choice for treating gout and is instead only used when patients show complications while using the preferred drug allopurinol.
Gout Treatment Options: Febuxostat Versus Allopurinol
Gout is a painful condition caused by the buildup of uric acid in the body. In a healthy person, the person’s kidneys are usually able to process excess uric acid in the body. When that uric acid is not effectively processed, however, the uric acid can crystalize into urate crystals that can then accumulate in a person’s joints.
Clinical trials involving Uloric (febuxostat) and allopurinol showed that individuals who took Uloric over allopurinol to treat gout were at an increased risk of death from all causes, including heart attacks and strokes. The trial concluded that for every 1,000 patients who took Uloric, 15 would die from heart-related issues (11 such deaths were reported for allopurinol) and 26 would die from any cause (22 for allopurinol). It is unclear why allopurinol presents a smaller risk for patients than Uloric.
Symptoms of Trouble with Febuxostat
Patients should be aware of the troubles documented with Uloric if their doctors prescribe generic febuxostat as a treatment option. Given that Uloric was considered a “back-up” treatment option and that treatment with allopurinol is the preferred drug, patients may consider asking their doctors for a prescription of allopurinol if febuxostat is prescribed. If a patient does take febuxostat, he or she should seek immediate medical help if they experience chest pain, rapid heartbeat, or recognized signs of a stroke like weakness or numbness on one side of the body and trouble with vision or speaking.
What are the Signs of Serious Uloric Injuries?
Cardiovascular injury and other serious medical complications from the drug Uloric will exhibit certain signs and symptoms. As a patient who is taking or has taken Uloric for gout, you should look for the following signs of a serious health risk:
- Pain in your chest
- Difficulty catching your breath or shortness of breath
- Abnormal heartbeat or rapid heart beating
- Weakness in one side of your body, numbness in one side, or facial drooping
- Slurred speech or difficulty forming words and sentences
- Dizziness and loss of balance
- Severe headache with sudden onset
The FDA recommends that you seek immediate care from a health professional if you are experiencing any of the above symptoms. This does not mean making an appointment with your doctor for a later time; This means going to an emergency room right away
In addition, if you have a history of cardiovascular conditions, heart problems, or stroke, your physician needs to know this information. Your doctor will likely not want to prescribe Uloric due to the drug’s link to cardiovascular events and stroke.
Why Choose Parker Waichman for Your Uloric Case?
The defective drug liability lawyers at Parker Waichman LLP are nationally recognized and have a reputation for not only outstanding results but also for superior client service. We have fought for our clients’ deserved compensation with awards totaling more than $2 billion.
We understand the pain and emotional trauma you and your family have endured because of Uloric injuries, and we want to help you hold the manufacturer responsible. Our plaintiffs’ personal injury law firm has been at the forefront of complex drug litigations like Uloric. We know what it takes to achieve the settlement you need, and we will work tirelessly to obtain justice on your behalf.
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