More than 8 million people in the United States are afflicted with the painful form of arthritis known as gout. In 2009, physicians began to treat gout with febuxostat, an anti-inflammatory drug that is sold under the trade name “Uloric”. Almost as soon as those treatments began, patients reported serious side effects that in many cases were worse than the symptoms of the gout that the drug was designed to treat.
The febuxostat drug liability lawyers at Showard Law Firm are now reviewing cases regarding gout medication injuries. If you or a loved one has experienced heart problems, premature death or other serious side effects after taking Uloric, please contact us for a free and confidential case consultation. You may be eligible to file a gout medication lawsuit against Takeda Pharmaceuticals, the manufacturer of Uloric, and other entities that failed to warn patients of the known risks associated with febuxostat.
Gout Medications Lawsuits
Shortly after the Food and Drug Administration approved febuxostat for use in treating gout, physicians began to see increased heart ailments and other unexplained problems in their patients who were using the drug. A 2017 study confirmed that patients who were taking febuxostat were experiencing a statistically higher rate of heart issues, including premature deaths from heart failure, than those patients who used the older Allopurinol drug. After the results of that study were released, gout patients who suffered these adverse side effects and family members of patients who had passed away began to contact drug injury lawyers to discuss the possibility of filing Uloric lawsuits against Takeda, alleging that the company was aware of the adverse side effects associated with Uloric, but failed to warn patients about the risks.
FDA Adds Black Box Warning to Febuxostat
As more reports of adverse side effects and premature deaths reached the FDA, in February 2019 the agency took the rare step of requiring Takeda to include a Black Box Warning with the prescribing information for febuxostat. Black Box Warnings are the most prominent warnings that the agency can require a drug manufacturer to use. The Uloric FDA warning requires prescribing physicians to counsel their patients about the heightened risks of cardiovascular problems when taking Uloric.
Consumer groups have urged the FDA to recall Uloric. Specifically, they have asked the FDA to force Takeda to withdraw Uloric as a drug treatment for gout. As of April 2019, however, the agency has limited its actions to requiring Takeda to include the Black Box Warning and to make Uloric a second-line treatment for patients who are not responding well to the traditional allopurinol drug.
Uloric Side Effects
Adverse febuxostat side effects include:
- Cardiovascular problems, including an increased risk of heart attacks, strokes, heart arrhythmias, and unstable angina;
- Kidney impairment in patients who also have known renal issues;
- Some potential for liver problems.
Patients who have been using Uloric should contact their prescribing physicians immediately if they are experiencing chest pains, shortness of breath, unusual heart rhythms, any numbness or dizziness, headaches, or any other common symptoms of heart attacks or strokes. Showard Law Firm cautions patients not to discontinue use of a prescribed medication without first consulting your doctor. If you have not experienced any heart-related side effects of your gout medication, ask your prescribing physician if your medical history puts you at higher risk of developing cardiovascular problems while taking febuxostat.
Gout Drugs and Mortality Risks
The 2017 study revealed that Uloric users had a significantly higher risk of mortality than allopurinol users. A 2018 New England Journal of Medicine article stated, “All-cause mortality and cardiovascular mortality were higher with [Uloric] than with allopurinol.” The report does not identify the causal mechanism for this increased incidence of fatalities. In some cases, patients that have been diagnosed with gout may be suffering from other ailments, such as diabetes and heart disease, which might be responsible for premature death. The gout medication lawyers at Showard Law Firm will continue to analyze the febuxostat mortality risk and, if that risk is verified, the families of the patients who died while using febuxostat may have a valid cause of action to file a claim for wrongful death.
Are You Eligible to File a Uloric Lawsuit?
Please contact the drug liability lawyers at Showard Law Firm if you are suffering from any unusual side effects after you started taking Uloric. You may be entitled to compensation for any increased medical expenses or any economic losses you have experienced as a result of those side effects, as well as damages for pain and suffering and other losses.
We represent clients across the United States who are fighting to recover compensation from drug product manufacturers that place profits over patient safety. Call today for a free and confidential case review with a knowledgeable and experienced Uloric lawyer.
- fda.gov: FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (febuxostat). https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm
- mayoclinic.org: Gout. https://www.mayoclinic.org/diseases-conditions/gout/symptoms-causes/syc-20372897
- renalandurologynews.com: Mortality Risks Higher with Febuxostat vs Allopurinol. https://www.renalandurologynews.com/home/news/nephrology/hyperuricemia/mortality-risks-higher-with-febuxostat-vs-allopurinol/