The popular gout medication Uloric recently received a boxed warning from the U.S. Food & Drug Administration (FDA) due to an increased risk of heart-related death.
The U.S. Food and Drug Administration announced a medication commonly used to treat gout has a higher risk of death than competitive alternatives. The agency came to this conclusion based on an in-depth review during clinical trials of the medication.
Uloric (febuxostat) was approved by the FDA in 2009 to treat gout, a type of arthritis in adults. According to the agency, nearly 8.3 million adults in the United States suffer from gout. There are limited numbers of medicines on the market available to treat gout.
Uloric is prescribed to patients when other medications (such as allopurinol) used to treat gout are not conducive or useful in treating the chronic disease. It is prescribed to be taken once a day, typically with 40mg but can be increased to 80mg.
In 2019, the FDA determined it will require a boxed warning to be placed on all prescriptions of Uloric. The boxed warning, also known as the “black box warning” is the most severe warning the FDA can assign. It is only used when there is reasonable evidence that a medication is likely to cause serious or life-threatening side effects.
There has been an increase in heart-related events such as cardiovascular death, heart attack and stroke for those taking Uloric.
Uloric should not be stopped abruptly. Talk to your health care professional if you are considering stopping the medication.
Seek emergency medical attention immediately if any of the following side effects occur while taking Uloric:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache
Uloric falls under the category of a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels for adults with gout. Uric acid comes from a substance called “purines” in the body, as well as some foods and drinks. Uloric causes the body to stop producing uric acid from purines.
In addition to the boxed warning, Uloric side effects include liver problems, gout flare-ups, joint pain, rash, and nausea. Gout flare-ups happen when crystals dissolve into the joints as uric acid levels subside.
Hyperuricemia is oftentimes caused in patients with gout. It is an abnormally elevated level of uric acid in the blood. Though the correlation between gout and hyperuricemia is still unknown, studies have shed some light on the issue of the two. According to a study conducted by researchers, 20% of both men and women with gout had hyperuricemia.
UPDATE: (Oct. 28, 2019) On Monday, a man who has filed a lawsuit against Takeda Pharmaceuticals over Uloric, said the company failed to warn both doctors and patients about the “dangerously defective” medication.
Peter Gust Karidis said in his lawsuit that he suffered a heart attack in 2016 after using Uloric. He further claims the company intentionally concealed the connection of Uloric to “major adverse cardiovascular events” by submitting false reports to the U.S. Food and Drug Administration.
Takeda is being accused of intentionally ignoring patient and health care provider reports that indicated this very problem.
“Rather than doing adequate testing to determine the cause of these injuries or rule out Uloric’s design as the cause of the injuries, defendants continued to market Uloric as a safer and more effective prescription drug as compared to other available alternative treatment for hyperuricemia and gout.”
Karidis claims the FDA initially asked Takeda to conduct additional studies of Uloric that contained febuxostat. The trial studies were supposed to run from 2007 to 2014 but they didn’t finish until much later. The end result? Febuxostat has a higher likelihood of all-cause mortality and cardiovascular mortality than allopurinol. The very cause of Karidis and hundreds of others heart problems associated with Uloric.
Fortunately in February of this year, the FDA required the drug manufacturer to include a black box warning of cardiovascular events on all Uloric labeling.
Karidis is suing for strict liability and negligence, and is seeking damages that will cover the cost of future medical care and the loss of wages from employment.