Have you or a loved one suffered a heart attack, stroke, or died while taking Uloric to treat gout?The FDA recently warned that patients taking the gout medication Uloric (febuxostat) face an increased risk of serious injuries or illness. Uloric injuries have included heart attack, stroke, and death. If you or a loved one suffered an injury due to this gout medication, we urge you to contact our Uloric lawyers for a free case consultation.
FDA Claims Uloric to be DangerousIn February 2019, the FDA issued a statement addressing the potential dangers associated with Uloric (generic name, febuxostat). Uloric is a medication used to treat gout. The FDA has been investigating the potential link between Uloric and severe side-effects since 2017. In the statement, the FDA concluded that there is an increased risk of death associated with Uloric when compared to another gout medicine called allopurinol. Specifically, they found an increased risk of heart-related death, as well as death from other causes associated with Uloric. In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for one year. In addition, there were 26 deaths from any cause per 1,000 patients treated for one year with Uloric. As a result of this study, the FDA is now requiring the makers of Uloric, Takeda Pharmaceuticals, to include what is known as a black boxed warning on their medication, as well as an updated medication guide to alert doctors and patients of the potential risks associated with Uloric.
What is Uloric?Uloric is the brand name of a drug called febuxostat that is prescribed to patients in order to lower blood uric acid levels in adult individuals with gout. Uloric (or febuxostat) is manufactured by Takeda Pharmaceuticals to treat a type of arthritis called Gout. Febuxostat works by stopping the body from turning naturally occurring purines, or those added to the body from food or drink, into uric acid. The medication was approved by the Food and Drug Administration (FDA) in 2009.
Who is Takeda Pharmaceuticals?Takeda Pharmaceutical Company is one of the top 20 largest pharmaceutical companies in the world and the largest pharmaceutical company in Asia. The company earns over $16.2 billion in revenue each year when considering their profits from 2012. The company mainly makes medicines that treat metabolic disorders, gastroenterology, neurology, inflammation, and cancers.
What is Gout?Gout is a type of arthritis in the body that occurs when uric acid builds up causing a person to experience a flare up which consists of joint pain, swelling, and redness. In order to understand gout, it is first helpful to understand arthritis. Arthritis is not a single or specific disease. In fact, it refers to general joint pain or joint disease. There are over 100 different types of arthritis and similar conditions. Arthritis is the leading cause of disability pain in the US and affects all ages, sexes, and races. According to arthritis.com, more than 50 million adults are suffering with some type of arthritis.
Common arthritis symptoms can include:
- and decreased range of motion.
Symptoms of GoutPeople with gout experience attacks, or flare ups, that are characterized by the sudden onset of pain in a certain joint followed by swelling, a reddening of the areas, and tenderness. The most common joint that is affected by gout is the joint at the base of the big toe; ankles, knees, wrists, fingers, and elbows are other common areas gout can affect. Since gout is a type of chronic arthritis, the above facts also apply to gout. Gout affects approximately 8.3 million adults in the US, but most commonly affects men between 40 and 50 years of age. Of course, women and even children can also develop gout.
Diagnosing and Treating GoutSince Uloric has been deemed to be dangerous, it leaves one wondering what other types of treatment are available for gout. In order to explore these other gout treatments, let's first take a look at how gout is diagnosed.
Diagnosing GoutLike all other illnesses and diseases, the most common way to diagnose gout is by using different tests that reveal markers and signs that one may have the rheumatic disease. Tests to diagnose gout include:
- Blood test. A blood test can be used to measure the levels of uric acid and creatinine in one's blood in order to determine if they have gout. Blood tests are not a comprehensive diagnostic test for gout, however, since blood test may show high levels of uric acid even though a patient has never experienced gout. Likewise, the inverse is possible in which a person experiences other signs and symptoms of gout without showing high levels of uric acid in their blood. Be this as it may, blood tests are still a great starting point.
- Joint fluid test. In a joint fluid test, a needle is used to draw fluid from an affected joint in order to identify visible signs that urate crystals are present in the joint fluid.
- Imaging diagnostics. X-rays and ultrasounds (and sometimes CT scans) can be used by a health care professional to see inside a patient's joints in order to rule out issues that may be causing joint inflammation. Imaging diagnostics are also used to detect urate crystals in the joint or the presence of a tophus, which is the depositing of crystalline uric acid in the joint. Both of these are signs of gout.
Treating GoutAs is evident from the issues caused by Uloric, gout is commonly treated with medications. Gout medications are used to treat existing inflammation attacks and to prevent future attacks.
Medications that Treat Gout
- Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin IB, etc.) and naproxen sodium (Aleve). NSAIDs reduce swelling and relieve pain in joints affected by gout.
- Prescription NSAIDs such as indomethacin (Indocin) or celecoxib (Celebrex).
- Colchicine (Colcrys, Mitigare). Colchicine decreases swelling and prevents or lessens the build up of uric acid crystals in the joints. It may also help relieve pain.
- Corticosteroids (prednisone). Corticosteroids can be given orally or through an injection into the joint to reduce and prevent swelling.
Medications that Prevent Gout AttacksFor those who suffer from routine gout attacks, medications are administered to prevent future gout attacks by lowering the level of uric acid in the blood. Other medications can be used to help the body to rid itself of the excess uric acid that causes gout attacks. Medications that can be used to prevent the buildup of uric acid include:
- Xanthine oxidase inhibitors (XOIs), such as allopurinol (Aloprim, Lopurin, Zyloprim). This category also includes the medication questioned in this article, febuxostat (Uloric).
- Probenecid (Probalan) and lesinurad (Zurampic).
Potential Injuries Linked to UloricBased on existing Uloric lawsuits and according the FDA's website, patients with gout taking Uloric should seek emergency medical attention if they experience any of the following symptoms:
- Pain in their chest or heart-region
- Difficulty or trouble breathing
- Rapid or irregular heart rate
- Numbness or weakness affecting one side of the body (this is a common sign of heart attack)
- Dizziness, vertigo, or trouble standing
- Difficulty talking or forming sentences
- Severe headache that comes on quickly
- Heart-related death
- Non-deadly heart attack
- Non-deadly stroke
- Unstable angina (inadequate blood supply to the heart which could be life-threatening)
- Death caused by above or similar situations, not related to heart