Uloric (febuxostat), a prescription medication used to treat gout by lowering uric acid levels, has been linked to an increased risk of cardiovascular death. In 2019, the FDA required a boxed warning — the most serious type of safety warning — on Uloric’s label after a large clinical trial found that patients taking Uloric had a higher rate of heart-related deaths compared to those taking allopurinol, an older and less expensive gout medication. For New Mexico patients who have taken Uloric and experienced cardiovascular events, understanding your legal options is important.
The FDA’s decision was based on the results of the CARES (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities) trial, which enrolled over 6,000 gout patients with pre-existing cardiovascular disease. The trial found that Uloric was associated with a 34% higher rate of cardiovascular death and a 22% higher rate of all-cause mortality compared to allopurinol.
Understanding the Risks of Uloric
The CARES Trial Results
The CARES trial, which was required by the FDA as a post-marketing safety study, produced alarming results:
- Cardiovascular death rate: 4.3% for Uloric vs. 3.2% for allopurinol
- All-cause mortality: 7.8% for Uloric vs. 6.4% for allopurinol
- The increased risk was observed primarily in patients with pre-existing cardiovascular conditions
FDA Actions
Based on the CARES trial results, the FDA took several actions:
- Required a boxed warning about the increased risk of cardiovascular death
- Limited the approved use of Uloric to patients who have failed or cannot tolerate allopurinol
- Required healthcare providers to inform patients about the cardiovascular risks before prescribing Uloric
Manufacturer’s Knowledge
Takeda Pharmaceuticals, the manufacturer of Uloric, has faced scrutiny over what it knew about cardiovascular risks and when. The CARES trial was initiated in 2010 but results were not fully reported until 2018. Questions have been raised about whether Takeda adequately communicated emerging safety signals to healthcare providers and patients during this period.
Legal Claims Related to Uloric
Patients who suffered cardiovascular events while taking Uloric may have product liability claims against Takeda Pharmaceuticals based on several legal theories:
Failure to Warn
If Takeda knew or should have known about the cardiovascular risks of Uloric and failed to adequately warn healthcare providers and patients, the company may be liable for failure to warn. The fact that the FDA ultimately required a boxed warning suggests that earlier warnings were inadequate.
Design Defect
If the risks of Uloric outweigh its benefits — particularly given the availability of safer alternatives like allopurinol — the drug may be considered defectively designed.
Negligence
Takeda may have been negligent in its clinical testing, post-marketing surveillance, or communication of safety information to healthcare providers.
Fraud and Concealment
If Takeda concealed or downplayed known cardiovascular risks to maintain sales, claims for fraud and concealment may be available, potentially supporting punitive damages.
Who May Be Eligible to File a Claim?
You may have a viable Uloric claim if you:
- Took Uloric (febuxostat) as prescribed
- Experienced a cardiovascular event such as heart attack, stroke, or cardiac arrest while taking Uloric or shortly after
- Suffered a cardiovascular death (family members may file a wrongful death claim)
New Mexico Product Liability Law
Strict Liability
New Mexico holds pharmaceutical manufacturers strictly liable for injuries caused by defective drugs, including drugs with inadequate warnings.
Learned Intermediary Doctrine
New Mexico recognizes the learned intermediary doctrine, which directs the manufacturer’s duty to warn primarily to the prescribing physician. However, this doctrine does not protect manufacturers who fail to provide adequate warnings to physicians.
Statute of Limitations
The statute of limitations for personal injury claims is three years from the date the injury was discovered or should have been discovered (N.M. Stat. § 37-1-8).
Compensation Available
- Medical expenses for cardiovascular treatment
- Lost wages and earning capacity
- Pain and suffering
- Emotional distress
- Loss of enjoyment of life
- Punitive damages for egregious corporate conduct
- Wrongful death damages
Frequently Asked Questions
Should I stop taking Uloric?
Do not stop taking any prescribed medication without consulting your doctor. Your physician can evaluate your cardiovascular risk factors and determine whether an alternative medication like allopurinol would be more appropriate for you.
Can I sue if I had a heart attack while taking Uloric?
You may have a claim if your cardiovascular event occurred while taking Uloric and you were not adequately warned about the risks. An attorney can evaluate your medical records and the timeline of your treatment to determine whether you have a viable case.
What if my doctor prescribed Uloric instead of allopurinol?
If your doctor prescribed Uloric without informing you of the cardiovascular risks or without first trying allopurinol, you may have a medical malpractice claim against the doctor in addition to a product liability claim against the manufacturer.
Is there a class action lawsuit for Uloric?
Uloric lawsuits are typically filed as individual cases rather than class actions, as each patient’s medical history and injuries are unique. An attorney can file an individual claim on your behalf.
Contact Dominguez Law for a Free Consultation
If you or a loved one suffered a cardiovascular event while taking Uloric, you may be entitled to compensation. At Dominguez Law, we have the experience to pursue complex pharmaceutical product liability claims.
Contact us today for a free, confidential consultation. There is no fee unless we recover compensation for you. Se habla español.
