The U.S. Food and Drug Administration (FDA) has concluded that individuals with gout who use Uloric may face an increased risk of death compared to those who use another gout medication called allopurinol. As a result of these findings, the FDA has limited the approved use of Uloric to certain patients whose gout cannot be treated effectively with allopurinol or those who experience severe side effects from allopurinol treatment. The FDA also updated the Uloric prescribing information to include a new patient Medication Guide and a Boxed Warning, the agency’s most prominent drug warning.
Uloric (febuxostat) is a xanthine oxidase inhibitor commonly prescribed to treat a type of inflammatory arthritis called gout in adults. Gout can occur when too much uric acid crystalizes and deposits in one or more joints, a condition called hyperuricemia, resulting in sudden attacks of severe pain, redness and tenderness in the affected joints. Uloric was approved by the FDA in 2009 and is meant to work by lowering uric acid levels in the blood. The only other medication approved to treat gout is allopurinol, which entered the market in 1966. In fact, Uloric was introduced as a safer alternative to allopurinol, which can cause kidney problems in users and has also been linked to rare but serious allergic reactions in some individuals with gout.
At the time Uloric was approved, the FDA included a warning on the drug labeling regarding the potential risk of adverse cardiovascular events in patients taking the drug and required the manufacturer, Takeda Pharmaceuticals, to conduct a large post-market clinical trial in order to further examine the safety of the medication. The FDA’s latest Uloric warning is based on an in-depth review of the results of that 2010-2017 clinical trial, which compared more than 6,000 patients with gout taking either Uloric or allopurinol. According to the FDA, the primary outcome of the trial was “a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring intervention, called unstable angina.”
“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said in its drug safety communication. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.” According to the FDA, Uloric treatment did not increase the risk of these combined events compared to allopurinol treatment. “However, when the outcomes were evaluated separately, Uloric showed an increased risk of heart-related deaths and death from all causes.”
In light of this potential risk of death and heart-related death from Uloric treatment, the FDA recommends that patients taking the medication alert their healthcare provider if they have a history of cardiovascular problems or stroke and seek emergency medical attention immediately if they experience any of the following symptoms:
Gout is a painful, chronic disease that affects roughly 8.3 million adults in the United States. Sadly, the number of medications approved to treat gout is limited and the FDA says that there is an unmet need for treatments for the condition. Still, patients always deserve to be properly informed of the potential risk of side effects they could face when taking certain prescription or over-the-counter medications, so they can make an educated decision about whether a specific treatment is right for them. For instance, patients suffering from gout would likely consider an alternative treatment to Uloric after discovering that the medication could increase their risk of death. If you or a loved one has suffered a serious complication from Uloric or another pharmaceutical drug, contact an experienced product liability lawyer as soon as possible to discuss your legal options.