FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (febuxostat)



Uloric (Febuxostat) was FDA approved in 2009 as a means to treat Gout, a form of arthritis. The FDA has since concluded that there is an increased risk of heart-related death and death from all causes from Uloric and now requiring a boxed label warning.

The makers of Uloric (Febuxostat) are also recommending that health care professionals reserve prescribing it only to patients that have failed to achieve relief from Allopurinol or those that were unable to tolerate Allopurinol.

The makers of Uloric, Takeda Pharmaceuticals, were forced to include a “precaution” about possible cardiovascular events in patients at the time of release but has since been updated to the most prominent warning, a boxed warning. Sadly, Takeda Pharmaceuticals was able to manufacture and sell Uloric in the US without any complication warning on the drug’s label for years.

A safety trial was conducted to compare the risks posed by both Allopurinol and Uloric. 15 deaths from heart-related causes per 1,000 patients taking Uloric was observed over a year’s time compared to 11 deaths from heart-related causes per 1,000 treated with Allopurinol. Additionally, 26 deaths from any cause, per 1,000 patients, was observed with Uloric use over that year compared to 22 deaths per 1,000 from Allopurinol. This trial, known as the CARE trial, suggested that Uloric was connected to significantly higher risk for fatal cardiovascular events like heart attacks, strokes, and unstable anginas.

The FDA has been fully aware of these potential complications as early as 2009 and even attempted to minimize the heart problems that Uloric could cause by only approving 40mg and 80mg doses as opposed to the 80mg and 120mg doses that Takeda Pharmaceuticals had requested. Sadly, it took until 2018 for the FDA to require the box label warning based on the results of the postmarket trial that was conducted (CARES).

Uloric (Febuxostat) has also been linked to abnormal liver function. People taking Uloric were shown to have three times higher than normal levels of transaminase. While it remains unlcear as to whether Uloric directly heightens those levels, physicians who prescribe Uloric are supposed to conduct a baseline liver test panel prior to starting Uloric and then continue to monitor for any changes.

Uloric (Febuxostat) has also been linked to severe and potentially fatal allergic reactions. Stevens-Johnson syndrome being one of these observations. Approximately one in 10 people who develop this syndrome fall victim and die from the disease.

The deceptive and faulty marketing that has allowed for years of uninformed use regarding the risk of cardiovascular events has led to numerous lawsuits against Takeda Pharmaceuticals.

Learn More Uloric (Febuxostat)

Learn More About Other Prescription Drugs for Gout

A Careful and Healing Gout Diet

Artichoke Powder for Gout and Joint Health

ARTICHOKE POWDER (Globe Artichoke)

A relative of the hepatoprotective Milk Thistle, is popular for its pungent taste which is attributed to phytochemicals found in the green parts of the plants called cynaropicrin and cynarin, sesquiterpene lactones with documented medicinal actions. The phytochemicals in artichoke have been well documented and the leaves rather than the flower have been found to be higher in medicinal value.

Artichokes contain a very high antioxidant content, and in fact, contain two compounds (apigenin 7-rutinoside and narirutin) that are so unique they aren’t found in any other plant.

Traditional uses have included support for sluggish liver, poor digestion and atherosclerosis. Artichokes offer concentrated sources of amino acids and even help to support the natural growth of probiotics for the digestive system.

Continue reading “Artichoke Powder for Gout and Joint Health”

Gout and Kidney Stones

Kidney Stones

Kidney Stones (renal calculi) are formed as a result of a buildup of dissolved minerals on the inner lining of the kidneys. Once they make their way into the urinary tract severe pain in the groin, stomach, or flank area can ensue. A decrease in urination coupled with a large amount of stone-forming substances can cause these types of stones to appear. These stones can be formed by the mixture of calcium with oxalate or phosphate; and/or the combination of uric acid and amino acid cysteine.

Much like Gout, Kidney stones are being diagnosed more and more in recent years. The same type of stones can develop in the bladder as well, but are much more uncommon and have remained relatively low and unchanged by comparison. Over the span of almost 30 years, the Mayo Clinic observed a significant rise in the incidences of kidney stones; particularly in adult women. With more accurate CT scans our ability to monitor and diagnose stones are partly behind a good portion of this rise in cases, but also goes hand in hand with the rise in Obesity and Diabetes Type 2. Diets high in sugar, unhealthy fats, and salt have been to blame for stones and this type of diet certainly fits the profile for all of these conditions.

Continue reading “Gout and Kidney Stones”

The Gallbladder: Facts and Myths

What is a Cholecystectomy

Cholecystectomies are one of the most over performed surgeries in the United States, and far too often, completely uncalled-for. Even in the presence of gallstones, one should always consider alternatives before rushing under the knife. The gallbladder is an essential organ responsible for collecting and storing bile in order to process and digest fats. To say that it can just be removed without consequence, is rather reckless. Aside from a number of potential dangers and complications stemming from its removal, weight problems and diabetes type two risks rise significantly.

Gallbladder attacks are often a sign of much larger problems, problems that do not simply disappear only once a small piece of that puzzle is removed. Our typical desire for instant gratification, coupled with the misconstrued notion that the gall bladder is an unnecessary organ, has led to an alarming number of these senseless surgeries.

Continue reading “The Gallbladder: Facts and Myths”

What is CRP and what does it have to do with your health?

What is CRP?

CRP stands for C-reactive protein.  This protein is produced by the liver in response to elements released from certain white blood cells known as macrophages; as well as elements released from fat cells (adipocytes.)  CRP levels rise in the presence of inflammation and take on a role to bind with chemical compounds that are released on the surface of a dying or dead cell.  This process is part of an immune system response to enhance the ability of antibodies and bacteria/pathogen eating cells (phagocytic cells) to eliminate damaged cells from the body.  Certain chronic inflammatory conditions cause the release of IL-6 (interleukin-6) that trigger the release of CRP.  IL-6 is a type of immune protein in the family of cytokines that can act as both an anti-inflammatory and a pro-inflammatory.

As discussed in previous blog posts, inflammation is a normal body process necessary for our body’s response to fight infection and injury.  It is a natural part of our immune system’s ability to send white blood cells and other chemical compounds to a trouble area of the body in an effort to help it heal.  However, in the presence of chronic conditions such as Arthritis, Colitis, Bursitis, Tendonitis, Gout, Heart Disease, Asthma, Diabetes, and more – the constant “fire” of inflammation can be disastrous, even deadly.
Continue reading “What is CRP and what does it have to do with your health?”

Electrolyte imbalances, Inflammation, and Disease

As we know, inflammation is the major underlying factor behind chronic, degenerative diseases.  The body’s cells work very hard to maintain pH balance in the body.  Our typical American diet and lifestyle is largely acidic and makes this process extremely difficult. 

When overly acidic imbalances are present in the body, the cellular health is compromised.  Decreased cellular oxygen levels and metabolic declines cause cells to ‘die off’ at a rapid rate.  As acidic residues increase, the body attempts to buffer these acids with alkaline minerals (calcium, magnesium, sodium and potassium) in order to excrete them from the body.  In the presence of such acidic diets and lifestyles, this buffering system can easily reach maximum capability, quickly leading to acidic waste storage in the tissues.

Cells require very specific ion balance.  Electrolytes must be maintained within specific limits to balance the pH of the body’s environment.  Even the slightest acid increases can quickly lead to inflammation of the organs and tissues. Continue reading “Electrolyte imbalances, Inflammation, and Disease”

Gout and Cancer Connection?

Gout and Cancer Connection?

Is there a connection between Gout and Cancer?  Gout is a common inflammatory disease with incidences largely increasing with each passing year and affecting younger and younger age groups  more than ever before.  Acute arthritis and hyperuricemia stems from purine metabolism dysfunction, causing urate crystals to deposit into the tissue leading to kidney stones, soft tissue growths, urate nephropathy and/or arthritis.  Epidemiological studies have been conducted to estimate the potential association between Gout and Cancer risks.  These studies have displayed a preeminent role of Gout in carcinogenesis.

Cellular death and higher turnover rates can bring about hyperuricemia and the formation of tumors (tumorigenesis.)  Even though strong evidence exists to show the connection between high serum uric acid levels and an independent increased risk of cancer, the subject remains disputable. Continue reading “Gout and Cancer Connection?”

Gout can be found in dogs and other animals

Excessive amounts of uric acid in the bloodstream are not limited to only humans. Gout can affect our loving canine and feline friends, as well. Whereas humans are more likely to experience crystal deposits in the joint extremities, animals tend to grow uric acid crystals in their urine. When animals are unable to assimilate calcium and other minerals, abnormal uric acid and calcium levels can also deposit into the paws, toes, elbows, neck, ears, and tongue. This is know as calcified skin lesions, or Casinosis Cutis, and more common in breeds such as Boxers and Boston Terriers. Calcium “Gout” can also create a chalky liquid that can ooze from the paws. Continue reading “Gout can be found in dogs and other animals”

New evidence of increased risk of death with Febuxostat (Uloric)

According to the latest CARES trial, the Gout drug Febuxostat (Uloric) failed up against Allopurinol when it came down to a combined rate of fatal and nonfatal adverse events for those that suffer with both Gout and Cardiovascular disease.  In fact, there was a significant increased risk of death for those that took this drug for Gout while also suffering from heart disease.

The trial was mandated by the FDA and consisted of 6,190 patients, 84% of which were men.  Cardiovascular risk is naturally increased in patients with Gout.  The study was attempting to look at any difference in outcome for these patients taking Febuxostat, a nonpurine xanthine oxidase inhibitor, or those taking Allopurinol, a purine base analogue xanthine oxidase inhibitor.  The patients were followed for a median of 32 months, and a maximum of 85 months.  Without diving into all of the ratio statistics, the all-cause and cardiovascular mortality rate was higher in the Febuxostat group, 34% and 22% higher respectively. Continue reading “New evidence of increased risk of death with Febuxostat (Uloric)”

Arthritis and Gout are no longer considered “old man diseases”……..and they are dangerous!

These painful joint conditions were once considered the inevitable outcome of old aging joints.  However, these painful conditions have more than doubled in the past 10-15 years, with a shocking amount of sufferers now found to be under the age of 40.  Doctors have seen the sharpest rise in patients in their 20’s and 30’s, some 30% since 2012, suffering from a disease that was once thought to be limited to royalty.  Not so coincidentally, the rise in obesity, Diabetes Type 2, and prescriptions such as low-dose aspirin and diuretics has occurred almost simultaneously.

Even still there is large percentage of the population that suffers silently having never been diagnosed, or sometimes misdiagnosed.  Gout especially can be overlooked by medical professionals due to inaccurate blood measurements of Uric Acid.  Unless the fluid is directly aspirated from the joint it can be difficult to identify.  Many that are under an attack at the time they are seen by a physician will have low to normal blood serum Uric Acid levels.  Why is this?  Continue reading “Arthritis and Gout are no longer considered “old man diseases”……..and they are dangerous!”