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FDA Advises Against Aspirin Therapy to Prevent First Heart Attack

Is aspirin a dangerous drug?

Is 81mg aspirin a dangerous drug?

"Take two aspirin and call me in the morning." For more than 70 years doctors have been using that phrase with patients who called about minor problems. Since simple ailments tend to subside by the next day, it's an easy way to make the patient feel better. In many cases, aspirin and time were all the patient needed.

Aspirin was one of the first miracle drugs and it all started over 100 years ago. A company that would come to be known as Bayer, formulated aspirin from salicylic and acetic acids. It was the first drug to be synthesized and many consider it the beginning of the modern pharmaceutical industry.

In the decades since it was introduced, it's been used to treat headaches, muscle aches, toothaches, rheumatic fever, mild to moderate pain and inflammatory diseases like arthritis, pericarditis and Kawasaki disease. The problem is, most things aspirin are used for are temporary conditions. Take a few, the problem subsides and you put the remaining pills back in the medicine cabinet. Drug companies don't make serious money unless it's something you take every day.

A real milestone in the use of aspirin happened in the mid-1970s. That's when researchers were able to show the connection between aspirin, heart disease and stroke.

Here's how it works. Inflammation is a component of plaque build-up. Inflamed plaque is one of the causes of a heart attack or a stroke. Aspirin decreases inflammation by blocking the action of an enzyme called cyclooxygenase. That in turn makes the body less able to produce prostaglandins, chemicals that facilitate the inflammatory response. By inhibiting prostaglandins, the body is less able to form blood clots that clog the arteries.

A low dose aspirin taken daily could help prevent further heart attacks or strokes caused by those artery-clogging blood clots. Suddenly aspirin could be prescribed for tens of thousands of new customers, and they would conceivably take it for the rest of their lives.

The marketing of low dose aspirin, taken daily to prevent heart attacks and stroke had begun. Unfortunately, the hype went beyond the research. Within a few years, Americans were led to believe aspirin should be taken by ANYONE with coronary risk factors.

On February 11th, 2003, Bayer Healthcare LLC filed a citizens petition with the Food and Drug Administration (FDA) to market aspirin for the primary prevention of a first myocardial infarction in patients with the following conditions:

  • chronic heart disease risk of 10% or more over 10 years OR
  • positive benefit-risk as assessed by their health care providers.

It took over 10 years, but on May 2nd, 2014, the FDA responded to that citizens petition. The FDA said it had, "reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

In other words, for people who have NOT already had a heart attack or stroke, the risk of bleeding in the stomach or brain was greater than the preventative benefits of aspirin. A low dose aspirin is only a good idea AFTER you've already suffered an attack.

The problem now is educating the public. Dozens of companies that sell aspirin have put the symbol of a heart on their packaging to make people associate taking the pills as a "heart-healthy" and preventative activity. It's time to end that association.

Sell once daily aspirin...

If you have NOT had a heart attack or stroke, think of the red heart symbol as a warning. Take aspirin daily and you risk serious or life-threatening bleeding of the stomach or brain. If you're truly concerned about your health, start an exercise program. Eat more vegetables and quit smoking. A pill won't fix a mistreated body and it could make things much worse. That's not my recommendation, that's the warning from the FDA.

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Updated 5/31/2015