FDA Reverses Its Position on Daily Aspirin

August 04, 2014 

Story at-a-glance

• The FDA recently reversed its position on taking daily aspirin if you haven’t had a heart attack, concluding that the risks outweigh the benefits
• Scientific studies have failed to prove that low-dose aspirin offers safe and effective protection from cardiovascular disease
• Aspirin can lead to serious medical problems such as gastrointestinal and intracranial bleeds, ulcers, kidney failure, blindness, and many more
• A safer, more effective approach to heart health is reducing chronic inflammation through diet, exercise, sun exposure, and grounding yourself to the earth

By Dr. Mercola

If you haven't had a heart attack, step away from the aspirin bottle... If you are one of the 40 million Americans who take an aspirin every day, you may want to heed the latest warning from the US Food and Drug Administration (FDA).

After many decades of promoting aspirin, the FDA now says that if you have not experienced a heart problem, you should not be taking a daily aspirin—even if you have a family history of heart disease. This represents a significant departure from FDA's prior position on aspirin for the prevention of heart attacks.

On its website, the FDA now says:1, 2

"FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called 'primary prevention.' In such people, the benefit has not been established but risks — such as dangerous bleeding into the brain or stomach — are still present."

Their announcement was prompted by Bayer's request to change its aspirin label to indicate it can help prevent heart attacks in healthy individuals. Aspirin generated $1.27 billion in sales for Bayer last year,3 and from Bayer's request, it appears they want everyone to be taking their drug.

But the FDA says "not so fast"—and rightly so. Evidence in support of using aspirin preventatively has gone from weak to weaker to nonexistent. This is why I've been advising against it for more than a decade. It looks as though aspirin, even "low-dose aspirin" (LDA), may do far more harm than good.

In fact, it is debatable whether or not aspirin has ANY protective benefits against cardiovascular disease, even if you have suffered a heart attack or stroke. Recent scientific studies have uncovered a number of serious side effects, suggesting that whatever aspirin may offer may be overshadowed by its risks, especially when safer natural alternatives exist.

As is true for nearly all medications, the longer we watch for side effects, the more we tend to find—even for drugs like aspirin that have been around for more than 100 years. Just because aspirin is an over-the-counter drug and has been around for more than a century does not mean that it's harmless.

Aspirin May Conceal a Cardiac Event in Progress

Roughly 800,000 Americans die from cardiovascular disease annually, which includes heart attacks and stroke. This is why heart health has been such a major focus, and why aspirin was hailed as a "wonder drug" by those who believed it was a safe and effective preventative. But that ship has sailed.

Nearly 10 years ago, Dr. John G. F. Cleland, a cardiologist from the University of Hull in the UK, wrote an excellent article published in the British Journal of Medicine4 casting doubt upon the efficacy of aspirin therapy for prevention of heart attacks.

Based on a series of meta-analyses from the Antithrombotic Trialists' Collaboration,5 which is an enormous body of research following more than 100,000 patients at high risk for cardiac events, Dr. Cleland concluded that aspirin therapy was not saving lives. Rather, aspirin seems to change the way vascular events present themselves.

The number of non-fatal events may be reduced, but the number of sudden deaths is actually increased, because what most physicians don't realize is that surprisingly aspirin can mask a cardiac event in progress.

Dr. Cleland also found that studies touting aspirin's benefits are seriously flawed and interpretation of those studies is biased. Since Cleland's original study, a deluge of scientific studies have further exposed aspirin's failure, which I have summarized in the next few sections.

Studies Show Aspirin Is a Dismal Failure at Preventing Heart Attacks

The following table lists, chronologically, a sampling of studies showing that taking aspirin may do more harm than good. Regardless of whether you're a man, woman, or diabetic, aspirin has failed miserably. This list of studies is not comprehensive. You will find much more information in the GreenMedInfo database, which lists more than 60 articles about aspirin's toxic effects.6

Study	Significant Cardiovascular Findings
American Heart Journal 2004 (WASH)	Patients receiving aspirin treatment showed the worst cardiac outcomes, especially heart failure
New England Journal of Medicine20057	Ten-year study at Harvard involving nearly 40,000 women found no fewer heart attacks or cardiovascular deaths among women receiving aspirin therapy
British Medical Journal 20098	Aspirin therapy for diabetics produced no benefit in preventing cardiovascular events
Pharmacoepidemiological Drug Safety 20099	Swedish researchers studying individuals with diabetes found no clear benefit for aspirin, but did note it can increase the risk of serious bleeding
Journal of the American Medical Association 201010, 11	Scottish study found that aspirin did not help prevent heart attacks or strokes in healthy, asymptomatic individuals with a high risk of heart disease
Journal of the American College of Cardiology 201012	Patients taking aspirin showed a higher risk for recurrent heart attack and associated heart problems
Expert Opinions in Pharmacotherapy 201013	British meta-analysis of 7374 diabetics concluded that aspirin does not lower heart attack risk

Aspirin Increases Your Risk of Bleeding

Not only has aspirin failed to reduce the prevalence of heart attacks and strokes, but the list of its adverse effects seems to grow greater the more that it is studied. Chief among these is gastrointestinal bleeding, as aspirin interferes with your platelets—the blood cells that allow your blood to clot. According to one article, long-term low-dose aspirin therapy may double your risk for a gastrointestinal bleed.14

Aspirin also increases your risk for a brain bleed, especially if you are older. One study found a high mortality rate for elderly individuals who had been taking aspirin prophylactically when they suffered a head trauma, resulting in deadly brain hemorrhage.15

Aspirin Destroys the Lining of Your Gastrointestinal Tract

Regular aspirin use also destroys the lining of your gastrointestinal tract, increasing your risk for duodenal ulcers, H. Pylori infection,16 Crohn's disease,17diverticular disease, inflammatory bowel disease (IBD), and intestinal perforations. More than 10 percent of patients taking low-dose aspirin develop gastric ulcers. The damage to your duodenum—the highest part of your intestine into which your stomach contents pass—can result in duodenal ulcers, which are prone to bleeding. Even low-dose aspirin is proven to cause problems.

A Japanese study found a higher incidence of bleeding at the ulcer sites of patients with duodenal ulcers taking low-dose aspirin (LDA) therapy, versus those not taking LDA.18 An Australian study also showed that aspirin causes gastroduodenal damage even at the low doses used for cardiovascular protection (80mg).19 And Japanese researchers found that aspirin had caused "small bowel injuries" to 80 percent of study participants after only two weeks of aspirin therapy.20

Even MORE Bad News for Bayer

Each year, 15,000 people die and 100,000 people are hospitalized as the result of aspirin and other NSAIDs—and these are probably conservative estimates. But aspirin may be one of the oldest killer drugs! Strong historical evidence points to aspirin overdose as a major contributor to high death tolls during the 1918 influenza pandemic. Aspirin toxicity can result in hemorrhage and fluid buildup in your lungs, which can result in death. If you are interested in the evidence for this, please read Dr. Karen Starko's fascinating paper in Clinical Infectious Diseases.21

Lending even more weight to Starko's work, an animal study in 2010 suggests that treating the flu with antipyretics (such as aspirin) may increase your risk of death. This study involved animals, but the results were compelling enough for the researchers to make an "urgent call" for human studies.22 Aspirin also depletes your body of important nutrients, including vitamin C, vitamin E, folic acid, iron, potassium, sodium, and zinc,23 as well as impairing your melatonin production.24 And in addition to aspirin's growing list of bodily assaults, routine aspirin use has been associated with even broader health problems, such as:

• Increased risk of one type of breast cancer in women (ER/PR-negative)25
• Increased risk of kidney failure
• Cataracts, macular degeneration, and blindness26
• Hearing loss27 and tinnitus28
• Erectile dysfunction: Aspirin and other NSAIDs have been linked to a 22 percent increase in your risk of erectile dysfunction (ED), according to Kaiser researchers who studied more than 80,000 men29

The Real Key to Protecting Your Heart Is Reducing Chronic Inflammation

Getting back to the subject of your heart, with all of these adverse effects, why risk taking aspirin when there are safer and more effective alternatives? About one in three deaths in the US are attributed to cardiovascular disease—but 25 percent of those are preventable.

The key is to address chronic inflammation, which can be accomplished by making specific lifestyle changes that encompass diet, exercise, sun exposure, and bare skin contact with the earth. In the remainder of this article, I will focus on heart-health strategies that work FAR better than aspirin. For additional information, please refer to our prior article about cardiovascular disease.

Heart Health Tip #1: Adopt a TRULY Heart-Healthy Diet

My "heart-healthy diet" is vastly different from what government regulators and most conventional cardiologists recommend—because mine is actually based on science. The following table summarizes my basic nutritional recommendations, all of which will help quell chronic inflammation. For further guidance about how to proceed with your diet, I suggest reviewing myOptimized Nutrition Plan.

Limit or eliminate all processed foods and genetically modified foods (GMOs)

Eliminate all gluten and highly allergenic, pro-inflammatory foods

Swap all trans fats (vegetable oils, margarine, etc.) for healthy fats like avocado, raw butter, nuts, seeds, and coconut oil

Eat at least one-third of your food raw, or as much as you can manage

Increase the amount of fresh vegetables in your diet

Consume naturally fermented foods every day, which improves microbial diversity in your gut and helps keep chronic inflammation at a minimum

Avoid artificial sweeteners of any kind

Limit dietary sugar, especially processed fructose. Restrict your fructose to less than 25 grams per day, from all sources, including whole fruits. If you have insulin resistance, diabetes, hypertension, or heart disease, you'd be well advised to keep your fructose below 15 grams per day

Eat organic foods whenever possible to avoid exposure to harmful agricultural chemicals, such as glyphosate

To rebalance your omega-3 to omega-6 ratio, take a high-quality omega-3 supplement, such as krill oil, and reduce your consumption of processed vegetable oils, which are high in poor-quality omega-6 fats and trans fats

Drink plenty of clean, pure water

Heart-Health Tip #2: Avoiding Trans Fat Is ESSENTIAL

Aspirin was thought to provide its protective action by inhibiting cyclooxygenase and thus favorably modulating inflammatory prostaglandins, which essentially decrease platelet formation and thus "thins the blood." However there are far more effective ways to favorably influence this pathway. I recently interviewed Dr. Fred Kummerow who is nearly 100 years old and was the first scientist to document the dangers of trans fats. If you haven't watched the video yet, I would strongly encourage you to do so.

In the interview Dr. Kummerow explains that trans-fats prevent the formation of prostacyclin that thins your blood. By diligently avoiding all trans-fats, your body will happily make prostacyclin and keep your blood thin so you avoid heart attacks and strokes. Avoiding trans fats is imperative for your cardiovascular health. This is a FAR more effective strategy than eating trans-fats and taking aspirin to thin your blood.

Heart Health Tip #3: Exercise and Change Your Eating Schedule

One of the primary benefits of exercise is that it helps optimize your insulin and leptin levels. Following the dietary guidelines above will move you closer to the mark, but adding exercise can bring you across the finish line. A sizable study published inThe Lancet found that a mere 15 minutes of exercise per day can add three years to your life—even if you have cardiovascular disease risks.30

If your fasting insulin level is above three, seriously consider restricting your intake of grains and sugars until your insulin level is three or below (in terms of fructose, aim for a maximum of 15 grams per day). You might want to incorporate intermittent fasting into your diet and exercise plan, which can accelerate your progress. Intermittent fasting increases insulin/leptin sensitivity and mitochondrial efficiency, reduces oxidative stress, boosts growth hormone production, and helps you shed excess body fat. This is important as insulin and leptin resistance are at the core of most all cardiovascular diseases.

Heart Health Tip #4: Improve Your Blood Viscosity by Grounding Yourself to the Earth

Earthing may actually be one of the best-kept secrets for preventing blood clots—it's an old practice gaining a new appreciation! In the simplest terms, Earthing (or grounding your body to the earth) is what occurs when you walk barefoot on bare soil, grass, sand, brick, etc. Free electrons are transferred from the earth into your body through your feet, and these electrons are some of the most potent antioxidants known to man.

One of the most important discoveries about Earthing is that it makes your blood less viscous, which has profound implications for your cardiovascular health because virtually every aspect of cardiovascular disease has been correlated with elevated blood viscosity. Earthing is so effective at achieving a blood thinning effect that anyone take prescription anticoagulants like Coumadin need to lower their dosage if they start to implement Earthing.

When you ground, your red blood cells have more charge on their surface, which forces them to repel each other, so they have less tendency to "stick together" and form a clot. This causes your blood to flow more easily and your blood pressure to drop. Even a very small blood clot can kill you if it lodges in a critical area of your body, so this "blood thinning" has profound health benefits. Research shows that it takes about 80 minutes for the free electrons from the earth to reach your blood stream and transform your blood. One warning: if you take Coumadin, Earthing is contraindicated as it may thin your blood too much.

By implementing many of the strategies outlined above, you will make far greater progress than relying on drugs such as aspirin, which nearly always come with adverse effects. Remember, heart attacks are not caused by an aspirin deficiency, as some would have you believe!

[+] Sources and References

http://articles.mercola.com/sites/articles/archive/2014/08/04/daily-aspirin-side-effects.aspx