Dangerous Drug Warning: Gout Drug Linked to Increased Risk of Cardiovascular Death
What is Uloric and has it really been linked to an increased risk of death?
Uloric (febuxostat) is a medication manufactured by Takeda Pharmaceuticals and used to treat gout. Takeda began marketing Uloric in 2009. Recent studies have linked Uloric to an increased risk of death due to serious cardiovascular side effects. In fact, some clinical studies have shown that the risk of death is generally higher for patients taking Uloric as compared to another gout medication (allopurinol) and that the risk of cardiovascular death is between 34% and 49% higher for patients taking Uloric. These findings were so alarming that the Food & Drug Administration (FDA) ordered Takeda add a “black box warning” advising that studies show a higher rate of cardiovascular death compared to those treated with a different gout medication and Uloric should only be used where a different gout medication has failed.
How does Uloric work?
Uloric is prescribed for people suffering from gout. Gout is a type of arthritis that occurs when increased uric acid deposits sharp crystals in the joints. This leads to bouts of redness, swelling, and excruciating (and sometimes even intolerable) pain. Over 8 million adults, mostly men, in the United States suffer from gout. Allopurinol (Zyloprim and Aloprim) has been used to treat gout since the 1960s, but in 2009, the FDA approved Febuxostat as a new drug to treat hyperuricemia (excess uric acid in the blood) and Takeda Pharmaceuticals began marketing the drug as Uloric. Uloric was considered to be an effective treatment for gout because it lowered the uric acids in the bloodstream and because it was an alternative to allopurinol. In February 2019, after learning of the increased risk of death, particularly the increased risk of cardiovascular death, the FDA ordered Takeda Pharmaceuticals to include the boxed warning on the product label and warnings found in patient medication guides linking use of Uloric with an increased risk of death, including cardiovascular death. The FDA also limited the use of Uloric to instances where the maximum dosage of the other gout drug (allopurinol) is ineffective or isn’t tolerated by the patient.
What is a Black Box Warning?
A black box warning is the strongest safety warning required by the FDA. Designed to call attention to a life-threatening risk, the warning is required to be placed in a box and bolded so that patients and medical providers will pay special attention to the warning. Takeda is now required to include the following information on its labeling and patient medication guides.
How did the FDA discover Uloric’s increased risk of death?
Takeda tried twice (in 2005 and 2006) to have the FDA approve Uloric. On the third attempt, in 2009, the FDA approved Febuxostat (Uloric) for use as a treatment for hyperuricemia (excess uric acid in the blood) on the condition that Takeda Pharmaceuticals also conducted a post-approval large safety clinical trial between 2010 and 2017. Takeda followed more than 6,000 patients treated with either Uloric or allopurinol. The study showed a significantly increased risk of heart-related deaths as well as deaths from all causes for those patients taking Uloric. After reviewing the preliminary results of the study at the end of 2017, the FDA issued a drug safety communication warning of the increased rates of heart-related problems and fatalities. But after reviewing the complete study in 2019, the FDA ordered the black box warning which warns of increased risk of death and restricts the use of Uloric as a second-line drug.
Why are people filing lawsuits against the makers of Uloric?
Although the FDA did not order the black box warning until February 2019, many people believe that Takeda knew or should have known from the earlier clinical trials that although Uloric was not any more effective than allopurinol, it nevertheless subjected users to a substantial increase in the risk of death —particularly cardiovascular incidents and death. At least one safety consultant who used to work at Takeda has alleged that the company knew about the risks of Uloric but failed to disclose that information to the FDA and public. There is also concern that Takeda may have manipulated and/or suppressed the data in its pre-approval clinical trial and studies.
Am I eligible to file a Uloric lawsuit?
Patients (or their surviving family members) who took Uloric may be able to file a lawsuit against the company if they suffered from a cardiovascular event after taking Uloric. We are still discovering what Takeda knew and when, but it is possible that you may be eligible if you suffered: heart attack, stroke, pulmonary embolism, deep venous thrombosis, and/or angina. To find out if your case is viable, sign up for a free consultation with The Cochran Firm.
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What compensation will I receive?
Each individual case is going to differ in the allowable compensation based on the laws of your state and the facts of your case. In general, however, plaintiffs may be able to receive damages for the following:
Medical costs related to the treatment of severe side effects
Lost income due to a disability or untimely death
Loss of companionship or consortium
Funeral expenses for wrongful death
During your free consultation, we will go over any other compensation you may be eligible to receive based on the facts of your case.
How Much Does a Uloric Lawyer Cost?
The Cochran Firm – Dothan is taking Uloric lawsuits on a contingency basis, meaning that we will only be paid if we help you receive money as part of your legal claim. When talking with us, you should be sure to ask any questions you have about fees and other costs related to your lawsuit.
One final note:
If you are currently taking Uloric, we encourage you to consult with your doctor immediately to re-evaluate whether Uloric is the best medication for treating your gout. If you’re using Uloric and you experience any of the following symptoms, you should seek immediate emergency medical attention:
Shortness of breath
Rapid or irregular heartbeat
Numbness or weakness on one side of the body
Sudden severe headache
The Cochran Firm – Dothan is evaluating cases for individuals and their family members that may have been affected by the dangerous side effects of Uloric. Contact us today for a free case evaluation.