Uloric Heart Failure, Stroke & Death Lawsuits
Uloric is a medication that doctors may prescribe to manage chronic gout. There are ongoing lawsuits against the manufacturer of Uloric, Takeda Pharmaceuticals, for cardiovascular risks associated with Uloric the company failed to disclose.
Patients who suffered adverse side effects from taking Uloric, including kidney damage or heart-related death, may have grounds for compensation.
If you or a loved one has taken Uloric for at least thirty days and is experiencing cardiovascular complications, talk to the drug recall and defect attorneys at Rosenfeld Injury Lawyers LLC. You may have grounds to join the emerging multi-district litigation (MDL) against Takeda Pharmaceuticals for marketing defects. Then, contact us for a free case evaluation.
Prescription Medication Uloric
Uloric (generic name febuxostat) is a prescription medication used to treat gout. Gout is a complex form of arthritis that can cause sudden and severe pain, swelling, and redness in the joints.
Gout can develop when there are excessive levels of uric acid (hyperuricemia) in the bloodstream. Uric acid compounds can form during the metabolism of nitrogen. Patients suffering from gout have a higher risk of co-morbidities, such as cardiovascular events.
Not many options for the treatment of gout are available. Allopurinol has been the go-to drug to prevent high uric acid levels. The use of Uloric removes extra uric acid. Uloric is the first new medication the U.S. Food and Drug Administration (FDA) has approved to treat gout in over forty years.
Unfortunately, the gout drug might not be the safest option for patients due to their adverse side effects.
The Risks of Taking Uloric for Gout
The FDA approved Uloric for the market in 2009, with the requirement that Takeda conducts a clinical safety trial. The FDA allowed Takeda to release Uloric with a Warning and Precautions label on the box for potential cardiovascular outcomes.
Over the next eight years, Takeda studied Uloric's effects in more than 6,000 patients. The results of this safety study were cause for concern. The study exposed the following severe side effects associated with Uloric compared to allopurinol, another gout medication:
- Increased risk of cardiovascular death
- Increased risk of death by all causes
- Increased risk of non-fatal heart attack
- Increased risk of non-fatal stroke
- Increased risk of unstable angina (inadequate blood supply to the heart)
The New England Journal of Medicine published the results of the Uloric study on March 12th, 2018. Before the release of the results, Uloric's marketing materials already held warnings of increased risk of cardiovascular events, gout flares, hepatic toxicity (liver damages from chemicals), and skin reactions.
As of February 2019, however, the FDA required Takeda to add a black box warning - the most severe type of drug warning - to Uloric, warning patients of an increased risk of death compared to allopurinol.
During a meeting between the Drug Safety and Risk Management Advisory Committee and the Arthritis Advisory Committee, panelist Steven Meisel (PharmD of Fairview Health Services) says that if the information from the Uloric safety trial had been available in 2008, the FDA would not have approved the drug.
Its cardiovascular risks are severe enough to invoke the need for a black box warning, but not enough to lead to a withdrawal of the drug from the market. The panelists voted against withdrawal due to the unknown mechanism causing cardiovascular problems on Uloric.
Signs of Cardiovascular Issues While on Uloric
Patients taking Uloric for gout should pay special attention to their cardiovascular health. Those with histories of cardiovascular problems or diseases should carefully consider the risks vs. benefits before deciding to take gout medicine Uloric.
The FDA warns that Uloric should only be the second line of therapy if allopurinol fails. Symptoms of heart problems and other serious side effects of Uloric that can appear suddenly and without warning may include:
- Chest pain
- Shortness of breath
- Numbness or tingling in parts of the body
- Fast or irregular heartbeat
- Fainting or lightheadedness
- Slurring of speech
- Blurred vision
- Severe headache
- Increased risk of heart-related death
Take any signs of something amiss seriously while on Uloric. Seek medical attention immediately if you experience any of the symptoms listed above. Do not stop taking Uloric until you have spoken to your doctor, as this could lead to a return of gout symptoms.
If you believe Uloric contributed to your cardiovascular issue, review your options with an attorney.
Rhabdomyolysis - Related Deaths
It is well known that Uloric (febuxostat) taken to treat gout can lead to serious, life-threatening cardiovascular (CV) events. However, the medication can also increase the potential of risk of developing rhabdomyolysis, where muscle fibers die and release myoglobin (protein) into the bloodstream.
Some of the common symptoms associated with experiencing rhabdomyolysis involve:
- Rapid heart rate
- Vomiting and nausea
- Abdominal pain
- Muscle weakness
- Difficulty moving appendages
- Shoulder muscle pain
- Lower back in phi muscle pain
- Brown or dark red urine
- Decreased urine volume
A failure to treat the condition with aggressive fluid replacement could increase the potential for kidney damage. Untreated, the kidneys are not able to remove concentrated urine and waste.
Uloric Heart-Related Deaths
About fifteen in every 1,000 patients taking Uloric suffered heart-related deaths, compared to eleven in 1,000 patients taking allopurinol. Also, twenty-six a thousand patients died from any cause while taking Uloric, compared to twenty-two deaths per 1,000 for allopurinol.
Further analysis of the Uloric study shows significant issues with the way Takeda delivered its results. Takeda failed to note that 57% of the 6,198 patients enrolled in the safety trial left prematurely.
The lead case investigator noted that these withdrawals were often due to gout flare-ups or the patients feeling that the drug wasn't taking good care of them. One panelist, Bruce Psaty (M.D. at the University of Washington in Seattle), says that this large withdrawal rate would have biased results, which makes the cardiovascular death risk with Uloric even more significant.
Takeda Pharmaceuticals Failed to Disclose Hazards
The FDA did not require a boxed warning of the increased risk of cardiovascular death while on Uloric until February 2019. Patients who had been prescribed Uloric over the last ten years, therefore, may not have been aware of the potential risks.
It was the drug manufacturer's legal responsibility to inform patients of known or foreseeable risks. Now, lawsuits are emerging that accuse Takeda Pharmaceuticals of failing to disclose known health hazards.
The data summary on Takeda's study concluded that Uloric did not increase the risk of combined events compared to allopurinol. When analyzed separately, however, Uloric shows an increased probability of cardiovascular-related death and death from all causes.
FDA Drug Safety Communications
In November 2017, the FDA alerted consumers of the increased potential of heart -related death taking Uloric and its generic febuxostat. The government agency recommended that healthcare professionals consider the efficacy and safety of the product before prescribing the medication to patients.
In January 2019, the Drug Safety and Risk Management Advisory Committee and Arthritis Advisory Committee held a joint meeting with the FDA. The committee's agreement was released to the public, showing that the committee did agree that "there is a consistent signal of cardiovascular death associated with febuxostat."
The following month, the Food and Drug Administration released a safety announcement updating their black box warning for patients taking the drug. The FDA stated that there is a recognized increased risk of cardiovascular events in patients taking Uloric compared to allopurinol.
The government agency advised clinicians to stop prescribing Uloric to patients unless they cannot tolerate the safer allopurinol. However, public advocates petitioned the FDA to remove Uloric (febuxostat) from the medical marketplace, citing dangerous side effects.
What We Know About Uloric Lawsuits
The boxed warning that now goes with Uloric tells consumers there is reasonable evidence that the drug is likely to cause severe or life-threatening side effects. This warning came several years too late, however, for thousands of patients.
In light of the safety study and the new FDA-mandated warning, many patients are coming forward and seeking restitution for damages they suffered while taking Uloric. Claimants around the world are seeking justice against Takeda for allegedly failing to disclose information about Uloric's health risks that the company knew about or reasonably should have known.
Product liability lawsuits aim to hold Takeda accountable for cardiovascular problems (such as heart attacks or heart failure), and related deaths that the company may have prevented had it announced known health risks.
A former Takeda pharmaceutical company safety consultant has issued a whistleblower lawsuit against the company, claiming that it knew of the risks associated with Uloric but did not inform the public.
According to the consultant's lawsuit, Takeda knew about the risks of kidney and liver damage, as well as bone marrow failure and the fact that Uloric could prove fatal if combined with certain other drugs. The lawsuit also alleged that the pharmaceutical company took further steps to conceal this information from consumers.
Although the courts ultimately dismissed the consultant's whistleblower claim, it brought to light many significant issues regarding Takeda's marketing of Uloric.
Uloric Lawsuit FAQs
Thousands of patients who have taken Uloric in the past or are taking it now have questions about the ongoing multidistrict litigation involving this drug and allegations against the manufacturer. Although product liability lawsuits can be complicated, an attorney can make it simple. Here are some of the most frequently asked questions we receive about Uloric lawsuits at Rosenfeld Injury Lawyers:
Is There a Recall on Uloric?
No. The FDA decided not to withdraw Uloric from the market despite the severe health risks now connected to the drug. Instead, the FDA issued a drug safety communication and now requires Takeda to place a black box warning on Uloric's packaging related to its severe side effects and cardiac death.
Can I Just Stop Taking Uloric?
The FDA recommends not to stop taking you Ulorick until you have discussed your health options with your health care provider. Stopping your daily doses could worsen your gout condition.
The results of an extensive clinical trial in-depth review revealed the increased potential risk of death when taking Uloric. All dangerous side effects associated with the medication are listed on the drug's black box warning label.
Is Uloric Safe?
The Food and Drug Administration recommends that healthcare professionals not prescribe Uloric for their patients who cannot tolerate safer medications like allopurinol.
Is Uloric bad for Kidneys?
Only a small amount of the medication is excreted when urinating, which makes it safe to use in patients that suffer from kidney issues. However, doctors often prescribe allopurinol in low doses to treat gout for patients with impaired kidney function.
Is Febuxostat Safe for Renal Failure?
Studies show that Uloric (febuxostat) is effective and safe for individuals with moderate to severe renal (kidney) impairment. The pharmaceutical company that manufactures the medication recommends not adjusting the dose for these patients.
However, the safety and clinical efficiency of the medication in treating hyperuricemia has yet to be determined in renal transplant recipients and patients suffering from CKD (chronic kidney disease).
Does Uloric Cause Heart Problems?
Patients prescribed Uloric have developed severe heart issues, including heart-related death, stroke, heart attacks. However, researchers have yet to determine that Uloric caused these heart problems directly.
Have There Been any Lawsuits Filed in Connection to Medical Complications Related to Febuxostat?
Yes. Numerous multi-district lawsuits are arising from patients who have suffered severe health problems, including liver problems and heart-related death, while taking Uloric around the country. You may be able to join a mass tort or class action regarding this drug.
Can Gout be Cured?
Medical science and doctors have yet to find a cure for gout. However, physicians can manage the long-term medical condition using a combination of drugs to control information and uric acid levels. Medical treatment requires lowering the body's uric acid levels.
What is the Best Time of day to Take Uloric?
The pharmaceutical manufacturers of Uloric (febuxostat) recommend taking the drug in the morning, with or without food. Clinical trials show that it takes a few weeks to notice the beneficial results of using febuxostat.
What are the Warnings and Precautions of Taking Uloric?
A comprehensive cardiovascular outcome study showed that taking Uloric (febuxostat) increased the potential risk of cardiovascular death. Also, doctors have observed an increase in gout flares in patients taking febuxostat.
To combat this, the doctors prescribe taking an NSAID (nonsteroidal anti-inflammatory drug like Motrin or colchicine concurrently with Uloric.
Are There any Settlements of Uloric Lawsuits?
The FDA only issued a black box warning in February of this year. While lawsuits are currently emerging, none have yet been resolved. There is still time to join an MDL for this complex product liability lawsuit.
If you have other questions regarding Uloric lawsuits, our attorneys can answer them during a free consultation in for people impacted in Illinois and across the United States. We have a working knowledge of the claims against Takeda Pharmaceuticals and are always staying up to date with the latest developments involving the defective drug.
Compensation for Uloric Lawsuits
With help from an attorney, you and your family may be able to receive financial compensation from Takeda Pharmaceuticals for its negligence. A successful product liability lawsuit could result in payment for your past and future medical expenses, pain, and suffering, emotional trauma, lost income, and lost quality of life.
The courts may also award punitive damages to punish Takeda for its actions.
Contact Us Today to Discuss Your Legal Options Regarding Uloric Complications
If you have struggled with heart problems or stroke after taking Uloric, you may have grounds for a product liability claim against Takeda Pharmaceuticals. You may also be able to file for wrongful death if you believe Uloric contributed to the passing of a family member.
Rosenfeld Injury Lawyers has years of experience handling complex, dangerous drug cases throughout Illinois. Our law firm can conduct a case review, investigate and collect evidence, and help you fight for fair compensation.
Contact us online or call (888) 424-5757 today to discuss a personal injury case or wrongful death lawsuit.