Gout Pill Poses Major Risk for Your Heart

By Dr. Mercola

First identified by the Egyptians in 2640 B.C., gout was later recognized by Hippocrates, who referred to it as “the unwalkable disease.”¹ The condition appeared to be associated with a lifestyle often only afforded by the affluent, and so gained the label “disease of kings.” Today, however, science has a better understanding of how gout is triggered.

The prevalence of the condition has skyrocketed in the U.K., rising 64 percent between 1997 and 2012.² This is approximately a 4 percent rise every year, affecting nearly 1 in 40 people. The prevalence of the disease in the U.S. has also risen in the last 20 years, now affecting 8.3 million Americans.³

The reported prevalence of gout worldwide ranges from 0.1 percent to approximately 10 percent,⁴ with the highest reported in Taiwanese aboriginals and Maori. Gout is rarely found in the former Soviet Union regions, Guatemala, Philippines, Malaysia and Saudi Arabia.

If you struggle with the excruciating pain of gout, you may have been prescribed anti-inflammatory medication and drugs to address the underlying chemical cause of gout. A consumer advocacy group⁵ is pressuring the pharmaceutical company Takeda to remove their widely used gout medication, as recent research has demonstrated a 34 percent higher risk of death with use in those suffering from heart disease.⁶

Uloric Increases Risk of Dying in People With Heart Disease

Takeda is the largest pharmaceutical company in Japan and Asia⁷ and one of the top 15 companies in the world. They have a global presence in 70 countries, including the United States, Europe, Central America, Africa and the Middle East.⁸ The drug in question, Uloric (febuxostat), was approved by the U.S. Food and Drug Administration (FDA) in February 2009 for the treatment of gout and the chronic management of hyperuricemia.⁹

The approval followed two failed attempts in 2005 and 2006 out of concerns for increased cardiovascular risks observed in clinical trials. In response, the pharmaceutical company conducted a third trial that did not find the same cardiovascular safety risks.

This study reported the non-purine xanthine oxidase inhibitor was more potent than allopurinol taken daily. The same study reported,¹⁰ “The incidence of cardiovascular side effects was numerically higher with febuxostat than with Allopurinol, but this was not statistically significant.”

After putting the data together from all three studies, the FDA could not determine¹¹ “with much confidence” whether the drug posed a greater risk. So, in approving it, the FDA issued a warning on the drug label and asked the company to run a larger, post-marketing study to further assess the drug’s safety.

However, the follow-up study did not confirm these results.¹² In total, 6,190 patients were randomized and received either Uloric or Allopurinol. The group all had an elevated risk of cardiovascular and chronic kidney disease, as is commonly found in those suffering from gout. Half of the individuals remained in the study for at least 32 months and over half did not stay on either of the drugs.¹³

The rate of gout flares was nearly identical: 0.68 per patient per year taking Uloric and 0.63 per patient per year taking Allopurinol. While the rate of flare-ups was exceedingly similar, the rate of cardiovascular death was not. The researchers found the risk of death from heart disease was 34 percent higher in patients using Uloric than in those using Allopurinol. Researchers also compared the rate of death in those taking Uloric from any cause and found the risk was 22 percent higher.¹⁴

Consumer Advocacy Group Petitions FDA for Removal

Based on these results, Public Citizen, a nonprofit consumer advocacy group, is pushing the FDA to remove Uloric from U.S. markets. The petition¹⁵ claims there is “overwhelming evidence that the serious cardiovascular harms of Uloric outweigh any purported clinical benefit.”¹⁶

In the decade since the medication was approved, Public Citizen's petition states it¹⁷ “has been aggressively marketed and prescribed to at least hundreds of thousands of patients who are unaware of the potential dangers.” Their petition also reports Takeda posted $1.9 billion in U.S. sales from 2012 to 2017.

Physicians Incentivized to Prescribe New Medications

When new drugs are available for prescription, doctors are often eager to use them, even when research data demonstrates they may not work any better than older medications. One reason for this is because drug companies influence physicians’ prescribing habits using strong marketing tactics, such as offering free meals, merchandise or even cash in the form of consulting fees.¹⁸ Pharmaceutical companies push new drugs because they are more expensive than older drugs and far more profitable for the company.

In the case of Uloric, it is 45 times more expensive than Allopurinol with nearly identical rates of prevention. Despite early studies, confirmed by the recent featured study, the medication also leads to a greater risk of heart attack. Pharmaceutical companies spend billions of dollars to influence (what they call “educate”) and entertain doctors around the world.¹⁹

On ProPublica's Dollars for Docs website,²⁰ you can find out if your doctor accepted money from the drug industry. By influencing prescribing habits pharmaceutical companies have found an effective way of boosting their bottom line. Many physicians have regular contact with the drug industry and their representatives. One study²¹ found doctors begin interacting with pharmaceutical representatives in medical school and often continue this relationship at a rate of nearly four meetings per month.

A study²² in the New England Journal of Medicine noted “most physicians (94 percent) reported some type of relationship with the pharmaceutical industry.”

Despite the high rate of relationship between doctors and pharmaceutical companies, many physicians believe they're not influenced by gifts of free food, free travel and speaking engagements, all essentially amounting to free money. They acknowledge there's a conflict of interest, but rationalize or deny that a relationship with the pharmaceutical industry influences their decision to prescribe certain medications to their patients.²³

However, while most physicians believe these gifts do not influence their decision-making, most would also rather their patients not know they receive anything from the drug industry. Not surprisingly, many patients surveyed in one study²⁴ said they would trust their physician less if they learned the physician accepted gifts worth more than $100 from the pharmaceutical industry or went on industry-sponsored trips or sporting events.

One-quarter in the same survey²⁵ went so far as to say they would be less likely to take a prescribed medication “if their physician had recently accepted a gift in return for listening to a pharmaceutical representative’s presentation about that drug.” While the pharmaceutical companies enjoy tempting physicians with incentives to write prescriptions for newer medications, which puts more money in their pockets, it is apparent many patients are leery of the idea that their health care may be influenced by these gifts.

What Is Gout and What Causes It?

Gout is a type of inflammatory arthritis that causes pain, stiffness, swelling and inflammation in your joints and other tissues.^26,27 Heat and redness may also be present in the affected joint. The disease usually attacks the joints of the big toe, but fingers, knees and hips are not spared. The symptoms of gout are associated with an excess amount of uric acid in your body, which is a normal waste product of fructose metabolism. High levels are often associated with high blood pressure, obesity and kidney disease.²⁸

Uric acid functions as both an antioxidant and pro-oxidant once inside the cell. By lowering uric acid too much you lose the antioxidant benefits, but when you have excessive levels, it begins to cause harm. When the metabolic process controlling the amount of uric acid in your blood fails to do the job effectively, gout ensues. The symptoms of gout can be excruciating and is described as one of the more painful forms of arthritis.

Although gout symptoms usually go away within 10 days, the problem can become lifelong when attacks occur with increasing frequency and severity over time. While traditional medication treatments may work in the short term, most also carry dangerous and long-term side effects. Since the condition is often lifelong, your physician may recommend you stay on drugs for long periods of time, which can be dangerous to your health.

There are several stages the disease normally follows.²⁹ The first is asymptomatic. While you experience no symptoms, uric acid levels are building in your blood and crystals are forming in your joint. During the acute stage, uric acid levels may spike and movement in crystals formed in the joint trigger an attack.

The inflammation and pain usually begin at night and intensify over the next 12 hours. While some never experienced a second attack, an estimated 60 percent will within the first year.³⁰ Interval gout is the time between attacks. You experience no pain, but the condition has not been reversed. Low levels of inflammation may damage the joint. Chronic gout develops when uric acid levels remain high over a number of years and attacks become more frequent. Over time, joint damage may happen, leading to loss of mobility.

Gout Increases Your Risk of Heart Disease and More

Although evidence of the disease is concentrated in the lower joints, gout also affects the bursae in your body.³¹ These are slippery sacks providing support to bones and soft tissue. In particular, the olecranon bursae in your elbow and the prepatellar bursae in your knee cap are most prone to gout flare-ups. Gout attacks can also spread to tendon sheaths, the two membrane layers around the tendons³² responsible for proper body movement.

Immediate treatment for the condition is crucial in order to reduce the potential for complications. One of these is the formation of tophi, lumps of uric acid that form below the skin and surround an infected joint.³³ These are painful and may result in extensive soft tissue injury, joint damage and nerve compression syndromes such as carpal tunnel.

Individuals with gout also have a higher risk for kidney and cardiovascular damage. One study discovered gout was a risk factor for coronary artery disease and vascular events in women, but not cerebrovascular disease leading to stroke.³⁴ The risks associated with gout were lower in men. One of the key metabolic abnormalities, hyperuricemia, has a known association with increased risk of cardiovascular disease. However, researchers are unsure of the causality.

Although the risk from hyperuricemia is a smaller magnitude compared to other cardiovascular risk factors, it is significant and plays a role in risk associated with drugs to treat gout and the increased risk for death associated from heart attack. Some theorize the acute inflammatory response precipitating urate crystals in the joint may also be associated with endothelial dysfunction, contributing to the risk of heart disease.³⁵

Gout is also associated with systemic inflammation, a known risk factor of heart disease, increasing markers such as erythrocyte sedimentation rate and C-reactive protein.

How to Treat Gout Naturally

In recent years the prevalence of gout has been rising in the U.S. and other developed countries as the condition is associated with the consumption of processed foods and a devotion to other unhealthy lifestyle habits. While indigenous people live hardy outdoor lives with exercise, nonprocessed and nutrient-rich foods, Westernized countries have shifted dietary preferences to highly processed foods. and many are now suffering from diseases like gout.

Taking medication long-term may increase your risk for experiencing side effects, some of which are deadly. By making a few changes to your lifestyle choices, you may be able to reduce your risk of gout or reduce your risk of another flare-up.