Gout Medication Uloric Linked to Increased Risk of Death

The U.S. Food and Drug Administration (FDA) is warning patients and doctors that the gout medication Uloric puts people at increased risk of death, especially heart-related death. The agency issued its warning in a safety announcement published Feb. 21, 2019. Uloric Heart Attack Lawsuits are now being filed following the FDA’s warning.

Gout is a kind of inflammatory arthritis that affects about 8.3 million people in the United States. It is caused when a naturally occurring substance in the body called uric acid builds up and causes sudden flare ups of redness, swelling, and pain in one or more joints. The most common joint affected by gout is the big toe joint. Uloric works by reducing acid buildup.

Gout is not curable, and the number of medicines on the market to treat gout are limited. The FDA’s warning about Uloric comes after an in-depth review of results from one safety clinical trial which found an increased risk of heart-related death and death from all causes with Uloric.  

In response to its findings, the agency required the manufacturer of Uloric, Japanese pharmaceutical giant Takeda, to place a black box warning on the drug’s label. Boxed warnings are the FDA’s most prominent warning, and are the last warning before a drug is recalled from the market. The agency also required a new patient Medication Guide, detailing the risks of taking Uloric for gout.

People who experienced cardiac problems while taking Uloric are now filing Uloric heart attack lawsuits against the manufacturer for their pain and suffering. Family members are also filing Uloric heart attack lawsuits against the manufacturer on behalf of loved ones who died while taking the medication.

Uloric and Cardiac Death

Uloric is a prescription drug used to treat a type of arthritis called gout. Uloric’s active ingredient, febuxostat, works to reduce the amount of uric acid that builds up in the blood, thereby reducing the pain and inflammation associated with gout. At the time it was approved by the FDA in 2009, the agency included a warning about possible cardiovascular events in some patients taking Uloric.

Due to this risk, the FDA required drugmaker Takeda to conduct a postmarket clinical trial to further investigate the safety of Uloric. The trial included more than 6,000 patients with gout who were treated with either Uloric or another medication called allopurinol. The trial found an increased risk of heart-related deaths, non-deadly heart attack, non-deadly stroke, and angina—a condition of inadequate blood supply to the heart requiring intervention—in patients taking Uloric. The results were published in The New England Journal of Medicine in 2018.

Though the results did not show that Uloric increased the risk of the events compared to allopurinol, they did show Uloric increased the risk of heart-related deaths and deaths from all causes in patients.

The FDA said there were 15 deaths from heart-related causes per 1,000 patients treated with Uloric for a year, compared to 11 deaths per 1,000 patients treated with allopurinol. 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 with allopurinol.

These serious adverse events eventually led to the FDA adding a boxed warning on the Uloric label in February 2019, alerting doctors and patients about the drug’s risks. It is important for patients to tell their doctor if they have a history of heart problems or stroke because they may be at increased risk for dangerous side effects. Patients should discuss the risks and benefits of Uloric with their healthcare professional.

If you experience any of the following symptoms while taking Uloric, call 911 or seek emergency medical attention right away:

• Chest pain
• Shortness of breath
• Rapid or irregular heartbeat
• Numbness or weakness on one side of your body
• Dizziness
• Trouble talking
• Sudden severe headache

Uloric Side Effects

Uloric is associated with possible side effects, like any prescription medication, and patients should check the Uloric label for more details about these side effects.

The most common side effects of Uloric include:

• Abnormal liver function tests
• Nausea
• Joint pain
• Rash

The most serious side effects of Uloric include:

• Heart problems
• Gout flares
• Liver problems
• Severe skin and allergic reactions

Tell your doctor if you experience signs and symptoms of these serious side effects.

Signs and symptoms of liver problems can include fatigue; loss of appetite; pain, aching, or tenderness on the right side; dark or “tea-colored” urine; jaundice

Signs and symptoms of skin and allergic reactions can include rash, sores around the lips, eyes or mouth; red and painful skin; swollen face, lips, mouth, tongue or throat; severe skin blisters; flu-like symptoms.

Risk of Kidney Failure & Uloric

Uloric may put people with severe renal impairment (kidney failure) at risk for dangerous complications. Before 2017, however, the Uloric label did not include dosing recommendations for patients with severe kidney failure because drug manufacturer Takeda insisted there wasn’t enough data to support the recommendation.

For eight years, doctors prescribed patients with kidney failure the same doses as those with healthy kidneys, until enough patients came forward with reports of injuries. In September 2017, the FDA required that Takeda add dosing recommendations for patients with renal impairment on the Uloric label.

The label now recommends patients with severe renal impairment be limited to a dose of 40 mg once daily. The recommendation for patients with mild to moderate renal impairment continues to be the same.

Report Adverse Side Effects

Patients are encouraged to report adverse drug side effects to the FDA. The agency tracks these safety issues and uses them to make recommendations, take action, and improve the quality and safety of drugs and other products.

To report an adverse side effect to the FDA, visit the MedWatch Voluntary Reporting Form website or follow this link directly to form.

Patients should not stop taking Uloric without talking with their doctor first. Stopping the medication without an alternative treatment can worsen symptoms of gout.

Whistleblower Lawsuit Accuses Takeda of Hiding Uloric Risks

Takeda faces accusations of concealing it had knowledge that Uloric and other popular drugs could cause serious side effects. The whistleblower lawsuit was filed by a former employee of the drug company, Dr. Helen Ge.

Dr. Ge was a contracted physician who worked for Takeda reviewing adverse event reports for four major drugs, including Uloric. As part of her position, Dr. Ge determined the seriousness of a reported event and whether the drug was responsible for the injury. Dr. Ge also determined whether the adverse event constituted a “safety signal,” or the need for additional safety warnings.

Dr. Ge worked for Takeda from September 2008 through January 2010. She left nearly one year after Uloric was approved by the FDA and marketed to millions of Americans with gout. Dr. Ge alleges her contract was terminated after she complained Takeda was improperly reporting adverse side effects to the FDA.

In 2011, Dr. Ge sued the pharmaceutical company over allegations Takeda failed to report adverse events promptly and accurately to the FDA. In her complaint, she said Takeda should have reported adverse events earlier, and that the company consistently took actions to resist label changes through under-reporting.

In her lawsuit, Dr. Ge alleged Takeda pressured her to falsify her medical conclusions and asked her to classify events as “non-serious” or change her causality assessment to “unrelated” to avoid the FDA’s requirement to report within 15 days. On multiple occasions, Dr. Ge asserts Takeda officials altered her assessments directly.

Dr. Ge also alleged Takeda told her to alter her analyses of adverse events that involved interactions between Uloric and other medications that senior citizens are likely to take.

Dr. Ge’s case was dismissed in 2013 by District Court Judge Dennis Saylor in the U.S. Court of Appeals.

Uloric Heart Attack Lawsuits

Patients who took Uloric for treatment of gout and experienced serious side effects, such as cardiovascular problems, may be able to seek legal recourse for damages suffered. These patients may qualify for a Uloric lawsuit against the drug manufacturer Takeda.

If you or a loved one took Uloric and suffered cardiovascular problems or other serious complications, you may be entitled to financial compensation. Call the experienced attorneys at Schmidt National Law Group today at 1-800-631-5656 for a free consultation and to see if you qualify for a Uloric lawsuit, or visit nationalinjuryadvocates.com to file a claim now.

Sources

Centers for Disease Control and Prevention. “Gout.” Updated January 2019. Accessed March 2019: https://www.cdc.gov/arthritis/basics/gout.html

U.S. Food and Drug Administration. “FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat).” Published February 2019. Accessed March 2019:http://media.ca1.uscourts.gov/pdf.opinions/13-1088P-01A.pdf

U.S. Food and Drug Administration. “FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric).” Published November 2017. Accessed March 2019: https://www.fda.gov/Drugs/DrugSafety/ucm584702.htm

Uloric prescribing label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021856s013lbl.pdf#page=19

United States Court of Appeals. UNITED STATES ex rel. HELEN GE, M.D. Accessed March 2019: http://media.ca1.uscourts.gov/pdf.opinions/13-1088P-01A.pdf