Death, Heart Attack & Stroke Risk
A black box warning has been issued by the U.S. Food and Drug Administration (FDA) about the increased risk of cardiovascular death in people who use gout medication, Uloric. The Agency has also recommended that Uloric be limited to use only in patients who do not respond to first-line treatment, allopurinol or who cannot take other medications for gout.
Results of a large clinical study showed that Uloric may increase the risk of cardiac death by about 34% and may increase the overall chance of death by about 22%. Takeda, Uloric’s manufacturer may be facing cardiac death lawsuits for cardiac complications and other serious side effects caused by Uloric.
Uloric Cardiovascular Death
Uloric is used reduce uric acid levels which cause the symptoms of gout. It was designed to be more effective and easier to dose than the first-line medication, allopurinol. Treatment of patients with allopurinol requires careful titration of the medication and frequent comparison to blood levels of uric acid, which may leave them with inadequate treatment.
Though Uloric may be effective for many patients, a large clinical study known as the CARES study has shown an increased risk of cardiac death. Patients who take Uloric are about 34% more likely to experience a cardiovascular event or condition that results in death. In addition, patients are 22% more likely to die of any cause when given Uloric.
The CARES study followed more than 6.000 patients who were taking Uloric or allopurinol and found that those who take Uloric are about 34% more likely to experience a cardiovascular event or condition that results in death. In addition, patients are 22% more likely to die of any cause when given Uloric. There was also an increase in cardiac events that were not fatal amongst the Uloric patients.
The study took place over a 7-year period and all patients were enrolled for at least 32 months, some as long as 6.5 months. Increased Uloric death risk was seen in patients across all groups regardless of age, gender or other medications they were taking. Patients who had a previous history of cardiac disease were at greatest risk.
Based on study results, consumer advocate, Public Citizen has called for Uloric’s withdrawal from the market. Experts have stated that if study results or similar information had been available at the time of Uloric’s introduction, the medication would not have been approved. Despite calls for Uloric to be recalled, the FDA instead has required a black box warning be added to drug labelling.
Uloric Cardiac Black Box Warning
In February of 2019, a black box warning was issued for Uloric. The new, mandatory boxed statement includes information about the increased risk of cardiac death and other causes of death in patients who take Uloric. It also recommends that use of Uloric be reserved for patients who have not responded to allopurinol or who cannot take allopurinol due to side effects or drug reactions.
Black box warnings are the most severe safety alert that can be issued by the FDA and are required to be printed at the top of all prescribing information, enclosed in a box with a thick, black border.
The safety alert containing black box information also stated that a new medication guide was to be issued for Uloric. The new guide provides consumer information about Uloric and advises patients to report cardiac information to their health provider.
Patients are also advised to seek emergency attention for symptoms of heart attack or stroke such as:
- Chest pain
- Shortness of breath
- Sudden pain in head
- Irregular or fast heartbeat
- Weakness or numbness on one side of body
- Difficulty with speech
- Changes in consciousness
Filing a Uloric Lawsuit
People are filing lawsuits against Takeda, manufacturer of Uloric, for injuries caused by the medication such as:
- Cardiac death
- Heart attack
- Heart failure
Uloric lawsuits are seeking compensation for damages including medical expenses, loss of income, and pain and suffering. In some cases, family members may be filing wrongful death Uloric lawsuits if their loved one has died from complications caused by the medication.
People or loved ones of those who have ben harmed by Uloric should seek legal advice.