FDA Information About Uloric-Related Death Risk
Based on an in-depth review of the results of a Uloric clinical trial, the FDA issued a “Boxed Warning” to the drug label in February 2019, indicating that “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” According to the FDA, Uloric treatment may increase the risk of heart-related death and death from all causes. As a result of these findings, the FDA took action to limit the approved use of Uloric to certain patients for whom allopurinol treatment is ineffective or causes severe side effects. A “Boxed Warning” is the FDA’s most serious warning, reserved for instances where one or more of the following apply:
• If an adverse event is so serious (death or a permanently disabling reaction) in proportion to the potential benefit from the drug that it is essential to consider when weighing the risks and benefits of the drug;
• If a serious adverse reaction can be prevented, reduced in frequency, or made less severe by following certain guidelines, such as patient selection, careful monitoring, or taking into account other medication that the person might be taking; and/or
• If there are mandatory restrictions for prescribing the drug. Some medication may only be administered in certain settings (supervised or inpatient) or may require the doctor to complete extra training in order to prescribe.
The FDA’s 2019 Uloric warning updated a previous drug safety communication published in 2017, which revealed an increase in heart-related deaths associated with Uloric treatment. According to the results of a safety study the FDA required Takeda to perform when Uloric was first approved in 2009, Uloric treatment was associated with an increased risk of “heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.”