Uloric is a xanthine oxidase inhibitor that is used in the treatment of gout. When the medicine works as intended, it prevents gout attacks from occurring. However, Uloric has been the subject of a recall request that has been made to the FDA in light of study results that have shown a linkage between the drug and increased cardiac deaths.
There has been an update to the boxed warning for the drug to reflect this added risk. Attorneys are now investigating the possibility of a Uloric lawsuit against the manufacturer of the drug on the grounds that the drug is defective.
Dangerous Drug Manufactured by Takeda Pharmaceuticals
Uloric is manufactured by Takeda Pharmaceuticals. It is designed to reduce blood uric acid levels. When these levels are elevated, patients are at risk of suffering attacks of gout that can be painful and debilitating. It is taken as a tablet to control gout, but it is not a cure for the condition.
The drug was approved by the FDA in 2009. The drug has been profitable for Takeda. From 2012 to 2017, it realized nearly $2 billion in sales from the drug. However, there have been concerns about an increase in cardiac events connected with the use of the drug. Initially, the drug was rejected twice before it was approved by the FDA precisely because of the cardiovascular risks involved. As part of the FDA’s approval, Takeda was required to conduct a study assessing whether Uloric led to a higher chance of death among patients taking the drug. The drug’s label warned consumers that there was a higher incidence of heart-related problems resulting from the use of the medication.
Increased Risk of Death
In 2017, there was a drug safety communication issued by the FDA regarding Uloric. This was to alert the public that there the study that Takeda was required to conduct showed that there was an increased risk of death associated with this drug. The study looked at results from over 6,000 patients who were using the drug. The communication represented that the FDA was going to further analyze the results of the study and update the public accordingly.
In the wake of the FDA’s communication, there was pressure on the FDA to order that this drug be removed from the marketplace. Public Citizen sent a petition to the FDA in June 2018 arguing that the drug has unique risks that outweigh the benefits. Federal regulations allow for petitions to the FDA to ask that certain actions be taken. The petition detailed many studies undertaken over a number of years that showed that this drug is dangerous.
The FDA’s Advisory Committee deliberated on the request contained in the petition. In February 2019, the Arthritis Advisory Committee voted 19-2 to include a recommendation that the benefits of Uloric outweigh the risks in the treatment of gout. The FDA almost routinely follows the advice that it receives from its advisory committees.
However, the FDA did require a major change in response to the study results. The company was instructed to update its warning label to reflect the increased risk of death associated with the use of this drug. The previous label only warned of heart-related events. In addition, the FDA directed that Uloric only be used as a second-line treatment. In other words, the drug should only be prescribed to patients who do not respond appropriately to treatment with allopurinol. While the drug remains in the marketplace, this is a serious reaction on the part of the FDA to the results of the study.
Here is a timeline of Uloric events:
- 2005 – Uloric application to FDA is rejected
- 2009 – Uloric is approved by the FDA provided that further study was undertaken
- 2017 – The results of the study show an increased risk of death
- 2019 – The FDA orders a black box warning
Contact an Experienced Drug Injury Lawyer
If you have had a loved one who has taken Uloric and passed away, you should immediately contact an attorney to discuss a possible claim against Takeda for selling a defective product. An attorney can provide you with a free case assessment and can inform you of the steps that would need to be followed in order to file a lawsuit against the company. There are currently investigations underway that may lead to lawsuits against the company. The Eichholz Law Firm has a deep reservoir of experience in achieving results for patients who have been harmed by defective medical products and pharmaceuticals. Call them today to see how they can help you.
- FDA. “Uloric (febuxostat): Boxed Warning Added – Due to Increased Risk of Death with Gout Medicine“, U.S. Department of Health and Human Services, https://www.fda.gov/safety/medical-product-safety-information/medwatch-safety-alerts-human-medical-products. Accessed March 19, 2019.
- Healio. “FDA adds boxed warning to febuxostat for increased mortality risk“, Healio Rheumatology, https://www.healio.com/rheumatology/gout/news/online/%7Bfe807284-bb20-4439-b657-a9332f886aaf%7D/fda-adds-boxed-warning-to-febuxostat-for-increased-mortality-risk. Accessed March 19, 2019.