Cardiac Death, Heart Attack, Stroke & Heart Failure
The U.S. Food and Drug Administration (FDA) has issued a boxed statement or “black box warning” for Takeda’s gout medication, Uloric. Black box information warns that Uloric may cause increased risk of cardiovascular death and states that the medication should be reserved for patients who did not respond to or cannot take allopurinol for treatment of gout.
Patients who suffered serious side effects and family members of those who may have died due to Uloric treatment are filing cardiac death or drug injury lawsuits against Uloric manufacturer, Takeda.
Uloric Gout Treatment
Gout affects about 8.3 million people in the U.S., most of whom are older. It is caused by high serum levels of uric acid and is characterized by painful, swollen joints which cause pain and difficulty moving. Medications used to treat gout work either by reducing inflammation and relieving pain or by reducing serum uric acid levels.
Uloric (febuxostat) works to treat gout by reducing formation of uric acid though inhibition of an enzyme known as xanthine oxidase (XO). It was introduced and marketed in 2008 as a medication which was easier to dose and more effective than the first-line treatment allopurinol which requires careful titration according to serum uric acid levels and may leave patients without enough pain relief. Unfortunately, the risks of Uloric may outweigh the benefits.
Uloric Cardiovascular Death
After Uloric’s approval in 2009, a large clinical study, known as the CARES study, was commissioned to examine cardiac side effects when compared to the first-line gout treatment drug, allopurinol. The CARES study followed more than 6,000 patients who took either Uloric or allopurinol for 32 to 80 months, examining patient reports for cardiovascular death, stroke, and non-fatal cardiac events.
CARES results showed that when compared to those taking allopurinol, patients taking Uloric had a 34% higher risk for cardiac death and a 22% higher risk for other causes of death. In addition, the Uloric group also had a higher risk for non-fatal cardiac events such as non-fatal heart attack. Patients who had a prior history of heart disease were considered to be at added risk but increased death risk and risk of non-fatal cardiac events was not affected by gender, kidney disease status, or use of other medications.
Because of the increased occurrence of cardiac death, some experts have said that if the risk had been known in 2009, Uloric would not have been approved. Consumer protection group, Public Citizen, has called for Uloric to be withdrawn from the market. Though the FDA has required a black box warning, no move towards recall has been made.
Uloric FDA Warning
In February of 2019, after results of the CARES study were addressed by an FDA advisory committee, the Agency issued a black box warning for Uloric. A boxed statement is the most severe warning that is issued by the FDA, requires that information about the increased cardiovascular risk be included at the top of all prescribing information for Uloric.
Uloric’s black box warning also includes a recommendation that Uloric be reserved for use only in patients who did not respond to or who could not take allopurinol for gout treatment.
The FDA also required the creation of a new medication guide to inform consumers of the risks of Uloric and advise them about potential symptoms of complications. The medication guide recommends that patients discuss their cardiac history with their doctor and advises patients to seek emergency treatment for symptoms of heart attack or stroke.
Symptoms of heart attack or stroke may include:
- Chest pain
- Rapid or irregular heartbeat
- Shortness of breath
- Numbness or weakness on one side of body
- Speech difficulties
- Sudden headache
Filing a Uloric Lawsuit
Takeda has been accused of manufacturing a dangerous product which can cause serious side effects or result in death. They have also been accused of failing to warn the public and medical community about the risks of taking the medication.
People who took Uloric and suffered serious side effects such as heart attack, stroke or heart failure or loved ones of those who suffered cardiac death after treatment with Uloric are filing lawsuits against Takeda. Uloric lawsuits are seeking compensation for damages including medical costs, lost wages, pain and suffering or wrongful death if a loved one has died.
Fill out the form or call for a case evaluation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.