For more than 40 years before the U.S. Food and Drug Administration (FDA) approved Uloric as a treatment for gout, most people were prescribed allopurinol, a gout medication that came to market in the U.S. in 1966. When Uloric was approved by the FDA in 2009 to treat hyperuricemia in adults with gout, it quickly became a popular first-line therapy for painful gout symptoms. However, what many patients taking Uloric to treat chronic gout didn’t know until recently, is that the medication may put them at an increased risk of heart attack, stroke and death. If you or a loved one took Uloric and has since suffered a serious cardiovascular side effect, do not hesitate to get qualified legal help from a Uloric injury attorney. Contact us today to find out if you are eligible to file a Uloric claim against Takeda Pharmaceuticals.
More than eight million people in the United States suffer from gout, a complex form of arthritis characterized by sudden attacks of severe pain, tenderness and redness in one or more joints. The cause of gout is attributed to high levels of a naturally occurring substance called uric acid in the blood, often occurring because the body produces too much of the substance or because the kidneys excrete too little. This accumulation of uric acid can cause sharp, needlelike urate crystals to form in the joints. Gout typically starts in the joint at the base of the big toe, but it can affect any joint in the body, including those in the knees, ankles, elbows, wrists, and fingers. Gout is a chronic disease and the number of medications approved to treat the condition is limited. Two of the most widely prescribed gout medications in the U.S. are Uloric (febuxostat) and the older gout drug allopurinol, both of which are designed to lower uric acid levels in people with gout, thereby reducing pain and inflammation.
Uloric was approved by the FDA in 2009. At that time, the agency required a warning about the potential risk of cardiovascular events in patients taking the gout medication and also required the manufacturer, Takeda Pharmaceuticals, to conduct a postmarket clinical trial to assess the drug’s safety. The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial included 6,190 people with gout who were treated with either Uloric or allopurinol and researchers found an increased the risk of heart-related deaths and deaths from all causes in the patients treated with Uloric. In light of these troubling findings, the FDA issued a drug safety communication in November 2017 regarding the potential for Uloric to increase the risk of heart-related death in users. In February 2019, the FDA added a Boxed Warning to the Uloric label and advised healthcare providers to reserve the drug for use in gout patients who cannot tolerate allopurinol or for whom allopurinol treatment is not effective.
Once the best-selling gout medication in the U.S., Uloric is now considered a second line of defense behind the older gout treatment, allopurinol. Unfortunately, because the Uloric postmarket safety trial required by the FDA was not completed until nearly ten years after the gout medication was approved in the U.S., many gout sufferers took Uloric for years with no notion that it could increase their risk of heart attack, stroke, or death. To minimize the risk of serious or potentially life-threatening side effects in Uloric users, the FDA recommends that patients taking Uloric for gout seek emergency medical attention as quickly as possible if they experience any of the following symptoms during treatment:
Since the FDA updated the Uloric drug label to include the risk of heart-related death and death from all causes, Takeda Pharmaceuticals has been hit with a growing number of lawsuits filed by Uloric users and their loved ones who allege severe or fatal side effects resulting from Uloric use. The Uloric lawsuits claim that Takeda failed to warn users of the potential health risks they could face by taking the gout medication. If you or someone you know has suffered a heart attack, stroke, or another serious medical condition that you believe to be related to the use of Uloric for gout symptoms, do not hesitate to speak to a knowledgeable Uloric attorney about your legal options. You may have grounds to file a Uloric lawsuit against Takeda Pharmaceuticals in order to pursue compensation for your losses.