What are the Dangers of Uloric?

New FDA Black Box Warning Mentions an Increased Risk for Heart Attacks

Uloric is a drug manufactured by Takeda, approved by the FDA in 2009 and used for gout—nearly 8.3 million adults in the United States have gout. Unfortunately, there are many dangers associated with Uloric, some of them more serious than others. According to the manufacturer, when taken regularly, Uloric can prevent damage to the joints, stopping gout attacks and possibly reducing the size of gouty lumps which affect the skin. The human body produces a substance known as urate which typically dissolves in the blood and is passed through the urine. Those with gout are unable to dissolve the urate, causing solid crystals to form around the joints, leading to severe inflammation and pain.

How Does Uloric Work? Uloric blocks the production of urate which brings down urate levels allowing the crystals to dissolve and, in turn, preventing gout attacks. Most people who try Uloric have already tried a drug known as allopurinol which works in a similar manner but can cause some people to have adverse reactions. Takeda states that Uloric is effective for the long-term treatment of gout—for those who have repeated attacks or those who have tophi—gouty lumps.

What Causes Gout? Those who have repeated bouts of gout should limit purine rich foods (certain meats, sardines, dried beans, green peas, cauliflower, mushrooms and beer), avoid sugar and alcohol, lose weight, add fiber and reduce stress. High levels of uric acid is known as hyperuricemia, which can lead to gout due to the acidity of blood and urine. While diet can be responsible for urate crystals building up, genetics, kidney disease, hypothyroidism, some types of cancers, diabetes mellitus, obesity and stress can also be contributing factors.

What are Some of the “Normal” Side Effects of Uloric? In the early stages of treatment, Uloric can actually cause an increase in attacks of gout. The manufacturer notes you should treat the attack of gout as you normally would. Some of the most common side effects of Uloric include diarrhea, headaches, skin rashes, nausea, abnormal liver test results and a build-up of fluid, usually in the lower legs and ankles. Unfortunately, these are not the only risks associated with Uloric.

Uloric Can Cause Death The FDA determined that those taking Uloric have a higher risk of death than those taking allopurinol. An in-depth review of results from a clinical trial found that not only did Uloric cause an increased risk of cardiovascular death, it also increased death from all causes. Because of these findings, the FDA has updated Uloric prescribing information to require a Black Box warning as well as a new patient Medication Guide.

Physicians Asked to Limit the Use of Uloric The FDA has also asked physicians to limit the use of Uloric to those patients who fail to get effective relief from their gout symptoms by taking allopurinol or those who have severe side effects from allopurinol. Patients should receive information regarding the cardiovascular risks of Uloric and should immediately seek medical attention if they experience chest pain, numbness or weakness on one side of the body, dizziness, a sudden, severe headache, difficulty speaking, a rapid or irregular heartbeat or shortness of breath.

Getting Help for Your Uloric Injuries - If you have suffered a heart attack after taking Uloric, it could be beneficial to speak to an experienced Uloric lawyer and consider filing a Uloric lawsuit. Uloric side effects can be severe—or even deadly, and the Uloric FDA warning has not significantly slowed sales of the drug. If you have gout symptoms and have taken the gout medication Uloric, a Uloric attorney can answer any questions you might have regarding a Uloric lawsuit.

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Author: Andrew Sullo
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Andrew Sullo

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Andrew Sullo is a National Trial Lawyer's Top 100 Selection for 2013-2018. He is also a member of the American Association of Justice.

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