Febuxostat—also known as “Uloric”—has unquestionably been fast-tracked onto the market, even though previous studies demonstrated alarming cardiovascular risks associated with the drug. Now, the Food and Drug Administration (FDA) has required that the manufacturer place a “Black Box” warning on the product, but it still has not recalled febuxostat even though the drug has now been shown to be linked to an overall increased risk of dying of any cause after taking it and has no real reported benefits compared to its alternative, allopurinol, as we discuss below.
The History of Febuxostat
Febuxostat was developed to treat hyperuricemia in patients with gout, a condition characterized by the presence of excessive uric acid in the blood, which then enters the bloodstream. When uric acid levels rise above a certain level, a patient can develop gout (a condition that involves the collection of uric acid crystals in their joints), as well as kidney stones. The drug works by blocking the conversion of xanthine to uric acid, therefore overall decreasing uric acid levels.
Febuxostat was approved by the FDA in 2009 based on a study known as the “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidity” (or “CARES”) post-market CV outcomes study; however, the drug’s labeling included a warning that a higher rate of cardiovascular events was observed in association with the drug.
Prior to febuxostat, gout was treated via another xanthine oxidase inhibitor known as allopurinol, which was approved by the FDA in 1966, and reportedly helps to prevent gout, but, in addition, according to some reports, carries with it a risk of causing gout if taken during a painful joint inflammation episode.
As of 2015, febuxostat was the 46th most prescribed brand drug in the U.S., with 1.3 million prescriptions, and its maker, Takeda Pharmaceuticals (with its product “Uloric”), making close to $2 billion in sales of the drug just between 2012 and 2017.
Citizens & Doctors Petition to Take Febuxostat off the Market Due to Alarming Studies
A number of citizens, including some doctors, have called for febuxostat to be completely taken off the market, noting that the drug has “serious, fatal” cardiovascular risks. Specifically, the petition, filed under the Federal Food, Drug, and Cosmetic Act and corresponding regulations, notes that there is enough scientific evidence proving that the cardiovascular harms vastly outweigh any purported clinical benefits, and, therefore, allowing it to stay on the market basically “ensures preventable harm.” The petition also notes that the FDA failed to require that an appropriately designed clinical trial be conducted prior to the drug’s approval.
It is true that, prior to the drug’s approval in 2009, available data from clinical trials did note a higher rate of heart-related death, myocardial infarction, and strokes associated with the drug. Although febuxostat was approved in 2009, this study reportedly did not conclude until 2017, and those citizens who filed the petition to get the drug taken off the market noted not only increased cardiovascular events associated with it, but also a higher risk of dying of any cause after taking the drug compared to allopurinol, without febuxostat offering any real additional benefits beyond allopurinol.
Other studies, such as the” Febuxostat Versus Allopurinol Controlled Trial (“FACT”), noted a higher incidence of self-reported gout flares during the first eight weeks of taking 120 mg of febuxostat compared to taking 80 mg of allopurinol, as well as a higher rate of death amongst those taking febuxostat, including those receiving 80 mg. Similarly, the “Allopurinol and Placebo Controlled Efficacy Study” (“APEX”) showed higher rates of serious adverse events amongst those who took febuxostat.
February 2019 FDA Warning—Why Not a Recall?
In February 2019, due to serious safety concerns, the FDA added a new warning to febuxostat, noting an increased risk of cardiovascular injuries and mortality compared to allopurinol. As a result, clinicians have been advised to only use the drug amongst patients who cannot tolerate allopurinol or who suffer from gout in very specific circumstances. Although, in January 2019, the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee decided that the benefits of using febuxostat outweighed the cardiovascular risks in certain, limited circumstances, a majority of the expert panelists involved still indicated that prescribing febuxostat should be relegated to “second-line therapy” for the treatment of hyperuricemia with gout in isolated cases.
Still, some would point out, if the drug wasn’t safe, surely the FDA would recall it, right? Not necessarily. Some have remarked that the FDA has been known to repay the industry by rushing risky drugs to the market, and that includes Uloric. The agency reportedly rejected the drug in 2005 and 2006 due to its associated cardiovascular risks; however, after the manufacturer itself conducted the third study (the “CARES” study), the agency suddenly changed its mind and allowed the drug onto the market. Even Takeda, after its eight-year study that concluded in 2017, found a significantly higher risk of death associated with its product. Although the FDA put out a public alert, it still left Uloric on the market.
If you take Uloric & Experience These Symptoms, Seek Help Right Away
- Chest pain;
- Numbness on one side of your body;
- Rapid heartbeat;
- Severe headaches; and/or
- Difficulty talking.
Contact Our Defective Drug Attorneys to Find Out More
If you or a loved one has been injured or killed as a result of taking febuxostat (“Uloric”), contact our experienced personal injury and defective drug attorneys today for a free consultation. We have the experienced and skills necessary to aggressively represent you and your family, and obtain the compensation that you deserve.