Uloric Heart Failure, Stroke & Death Lawsuits
Uloric is a medication 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 30 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.
What is 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 stems from excessive levels of uric acid in the bloodstream. Uric acid is a compound that forms during the metabolism of nitrogen. Patients suffering with gout have a higher risk of co-morbidities such as cardiovascular events.
Not many treatments are available for gout. Allopurinol has been the go-to drug to prevent high uric acid levels. This is a prescription drug that removes extra uric acid, like Uloric. Uloric is the first new medication the U.S. Food and Drug Administration (FDA) has approved to treat gout in over 40 years. Unfortunately, Uloric might not be the safest option for patients due to its negative side effects.
The Risks of Taking Uloric for Gout
The FDA approved Uloric for the market in 2009, with the requirement that Takeda conduct a safety clinical 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 serious 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 UloricPatients 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 Uloric. The FDA warns that Uloric should only be a second line of therapy if allopurinol fails. Symptoms of heart problems and other serious side effects 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
Did Takeda Know of the Risks?
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 10 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 for 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. About 15 in every 1,000 patients taking Uloric suffered heart-related deaths, compared to 11 in 1,000 patients taking allopurinol. In addition, 26 in 1,000 patients died from any cause while taking Uloric, compared to 22 deaths per 1,000 for allopurinol.
Further analysis of the Uloric study show 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 (MD 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 serious.
What We Know About Uloric LawsuitsThe boxed warning that now goes with Uloric tells consumers there is reasonable evidence that the drug is likely to cause serious 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 company knew or reasonably should have known about. 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 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 multi district litigation involving this drug and allegations against the manufacturer. Although product liability lawsuits can be complex, an attorney can make it simple. Here are some of the most frequently asked questions we receive about Uloric lawsuits at Rosenfeld Injury Lawyers:
Has Uloric Been Recalled From the Market?
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 serious side effects and cardiac death.
Have There Been any Lawsuits Filed in Connection to Medical Complications Related to Uloric?
Yes. Numerous multi-district lawsuits are arising from patients who have suffered serious 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.
Are There any Settlements of Uloric Lawsuits?
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 U.S. We have a working knowledge of the claims against Takeda Pharmaceuticals and are constantly staying up to date with the latest developments.
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 investigate your case, collect evidence, and help you fight for fair compensation. Contact us online or call (888) 424-5757 today.
- IMPORTANT SAFETY INFORMATION FOR ULORIC
- Drug Description
- FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
- FDA Adds Boxed Warning for Febuxostat
- Make Uloric Second-Line for Gout, FDA Advisors Say
- Takeda Announces Results from Uloric® (febuxostat) Cardiovascular Outcomes Trial in Patients with Gout and Cardiovascular Disease
- Comparing Febuxostat to Allopurinol in the Treatment of Gout