Recall on Uloric (Gout Medication)

Uloric, a doctor prescribed remedy to treat cases of gout, is a xanthine oxidase inhibitor. It generally stops gout attacks from occurring if used over a certain period of time and if it functions how it is intended to. However, Uloric is now under a recall request that was put in place by the FDA in response to a study in which the results have shown a link between the drug and the potential for cardiac death.

The newfound dangers of the drug reflect this added risk to the packaging, which has been updated. Attorneys are now determining if a Uloric lawsuit against the manufacturer of the drug is viable based on the claim that the drug is defective.

Dangerous Drug Manufactured by Takeda Pharmaceuticals

The drug Uloric is manufactured by a company called Takeda Pharmaceuticals. It’s designed to medically lower blood uric acid levels. Patients run the risk of suffering debilitating attacks of gout when these levels are elevated. Uloric is not a cure for the condition, but rather is used to control the most painful of attacks.

Uloric, which has been hugely profitable for Takeda, was approved by the FDA in 2009. Between the years of 2012 and 2017, they brought in roughly $2 billion in sales from that drug alone. Although the drug is performing well commercially, it was almost not put out on the market. The drug was rejected twice before it gained approval by the FDA because of the cardiovascular risks involved that are now surfacing. Takeda, at the request of the FDA, was forced to conduct a study that would determine whether or not Uloric led to an increased chance of death among its patients. Uloric’s warning label includes that it could lead to a higher chance of cardiac death if used.

Increased Risk of Death

The FDA in 2017 put out a safety communication regarding the use of Uloric. The purpose was to inform the public of the study that Takeda conducted which showed the increased risk of cardiac death tied to this drug. The study examined results from over 6,000 patients who were currently using the drug. The safety message was put out to ensure the public that the FDA was going to continue to analyze the results of the study and to update the public on their findings.

Once the FDA’s safety message was distributed, they came under scrutiny for not immediately moving to remove Uloric from the market. A petition was started by Public Citizen arguing that Uloric’s unique risks outweigh the benefits that it could potentially provide for patients. Petitions to the FDA are allowed through federal regulations to request that action be taken. The petition specifically detailed studies that showed Uloric was dangerous to patients.

The FDA’s Advisory Committee consulted about the details and requests contained within the petition. In a huge step towards removing the drug from the market, the Arthritis Advisory Committee voted 19-2 in February 2019 to recommend that the benefits of Uloric vastly outweigh the risks as it relates to the treatment of gout. The FDA routinely follows advice that it receives from its advisory committees.

Based on the results of the study, the FDA did require a major change in terms of the labeling of the drug. Takeda was required to update its warning label to reflect the increased risk of death associated with the ingestion of the drug, as the first version only warned patients of an increased risk of heart-related issues. The FDA also decided that Uloric can only be used as a second-line treatment, meaning that it should only be prescribed to patients who do not positively respond to treatment with allopurinol. Although the drug remains in the marketplace, this is a first step towards protecting patients from potential harm due to the adverse effects of the drug.

Timeline of Uloric events:

2005 – Uloric application to FDA is rejected
2009 – Uloric is approved by the FDA but requires that further studies be undertaken
2017 – Results of the study show an increased risk of death
2019 – The FDA requires a label change

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Prescription drug-related deaths and injuries are something that should be an anomaly, as federal regulations and the FDA are put in place to ensure that any drug on the market will not harm the majority of people. If you or someone you know has been prescribed or taken Uloric and subsequently experienced adverse effects, contacting a drug injury lawyer should be your next step. The lawyers from KBA Attorneys have years of experience handling drug-related injury cases and want to help you receive the compensation you deserve after this ordeal. Contact us today or fill out our online application for a case evaluation so we can advise you on the next steps.

References

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/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm631824.htm. 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.

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