The FDA has issued a new black box warning for the gout medication febuxostat (also known as Uloric) due to an increased risk of cardiovascular events associated with the medication. If you or a loved one suffered serious harm after taking this medication, please contact Lerner and Rowe Injury Attorneys today for a free Uloric case evaluation!
FDA and Uloric
Uloric was first approved by the US Food and Drug Administration (FDA) in 2009 for management of hyperuricemia, an excess of uric acid in the blood, in patients with gout.
Ten years later, there is some speculation that Uloric may be recalled, as the gout treatment was linked to more cardiac deaths than allopurinol, another well-known anchor drug prescribed to treat gout and cardiovascular disease.
These recall speculations developed after an increased risk of serious health concerns was brought up in the January 11, 2019 joint panel meeting of the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee .
In fact, because of these increased risks, it was determined that a black box warning needed to be added to all Uloric packaging. Furthermore, the FDA announced “Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol.” The FDA also suggested that doctors “Counsel patients about the cardiovascular risk with Uloric.”
From the first market release, Uloric’s package labels contained a general warning and precaution concerning cardiovascular events, such as heart attacks. This warning and precaution was included because initial clinical trials done prior to approval of the drug showed a higher rate of heart-related problems in patients treated with Uloric, as compared to allopurinol.
In a 2010-2017 postmarket clinical trial conducted by the FDA, trial outcomes increased concerns about the risk Uloric poses to users. It was determined that statistically, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year in patients treated with Uloric. In comparison, for every 1,000 patients treated with allopurinol for a year, there were 11 deaths from heart-related causes.” (Source)
In addition to cardiovascular events, Uloric has also been linked to increased cases of rhabdomyolysis, which, in the most severe cases, can cause death. Rhabdomyolysis stems from the death of muscle fibers and release of their contents into the bloodstream. Symptoms of rhabdomyolysis can include:
- Muscle pain in the shoulders, thighs or lower back;
- Weakness in the muscles;
- Pain the abdomen;
- Rapid heart rate;
- Trouble moving appendages; and
- Dark red or brown urine, or decreased urination.
These symptoms are especially troublesome for those who were first prescribed the drug for treatment of gout.
When the medication was first presented to the FDA, it was rejected. In the second NDA submission, 9 of the 12 total deaths among the subjects could be directly attributed to cardiovascular events. Following three phase 3 studies and two long-term extension studies, the FDA reviewers couldn’t determine conclusively whether Uloric poses a greater risk of cardiovascular events. The final determination from the 6,190 subject study were published. Researchers found that the overall adverse CV events were similar in both arms, but “…mortality and cardiovascular mortality were higher with [Uloric] than with allopurinol.” (Source)
Warnings, Risks, and Recalls
A black box warning is only required to be added to drug labels if use of the product shows potential risk of serious injury or death, which many believe is not stringent enough of a deterrent for people on this and other medications.
Due to the increased risks of myocardial infarctions and heart-related deaths, prescribing physicians were warned to carefully consider prescribing the drug to their patients with gout.
However, despite warning doctors, the general public was not initially made aware of the increased risks. Nor, after the risks had been discovered, had the drug manufacturer been asked to recall the drug; Public Citizen, a nonprofit consumer advocacy organization, called for the drug’s removal from the market.
Suffered Liver Damage? Kidney Failure? Rhabdomyolysis? Contact Us Today!
If you or a loved one has experienced a cardiac event, rhabdomyolysis, liver damage or kidney failure after taking the prescribed gout treatment drug Uloric, please contact Lerner and Rowe Injury Attorneys today.
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