FDA Finds Daily Aspirin Unnecessary for Heart Health

by DailyHealthPost Editorial

aspirin side effects

fda-finds-daily-aspirin-unnecessary-for-heart-healthAround about 30 years ago, aspirin was identified as a harmless drug that could prevent a heart attack or stroke. It was even suggested that the drug could prevent both events from ever occurring.

And so, people with cardiovascular disease, those who have already experienced a heart attack, and healthy people with or without a family history of heart disease were told by the medical establishment that one low-dose aspirin a day was an easy and effective way to significantly reduce their risk of a cardiac event.

Because of this practice, it’s estimated that forty million Americans take an aspirin every day.


Why This Is A Problem

In 2014, the United States Food and Drug Administration (FDA) reversed its position that daily aspirin can prevent the primary (i.e., first) risk of heart attack and stroke.

Its revised recommendations on aspirin’s use in the context of proactively promoting cardiovascular health were changed to the following:

“The FDA has 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 situations where the benefit of aspirin for primary prevention has not been established.” (1)

The FDA was prompted to make this official recommendation after reviewing and denying Bayer’s request to print on its labels that aspirin can aid in the prevention of heart attacks in people who have no history of heart trouble. In case you didn’t know, “Aspirin” is a Bayer trademark for acetylsalicylic acid (ASA).

In the Questions and Answers section on the FDA website, the reason for Bayer’s denial and its reversal of opinion are explained:

“FDA was aware of several ongoing studies for primary prevention in patients with diabetes and diseases of the arteries and veins located outside of the heart and brain (peripheral vascular disease). We opted to wait for the outcome of these studies. The results of these studies were published over the past several years.  They did not demonstrate a significant benefit for primary prevention…FDA is currently awaiting results of additional clinical trials that are underway and are estimated to have reportable results in the next few years. These clinical trials may provide new evidence that could be the basis for changing the current uses (indications) for aspirin.” (Ibid.)


And That’s Not All

A 2013 meta-analysis led by John G. F. Cleland and published in the European Heart Journal regarding the use of aspirin in primary prevention of heart attack and stroke supports the FDA’s recommendation, stating simply:

“There is no evidence that aspirin is effective for the primary prevention of cardiovascular events, although it may change the way that they present. Indeed, there is no evidence that long-term aspirin should be given to patients even with known cardiovascular disease.” [emphasis added] (2)

The phrase “it [aspirin] may change the way they present”, means that Cleland found that regularly taking aspirin can mask the symptoms of a heart attack because of the analgesic and blood-thinning effects of the drug. Think of it like cutting your lip after a shot of Novocaine—you won’t feel it now but will suffer from the damage later.

The potential for staving off a heart attack or stroke by taking aspirin, therefore, may reduce the numbers of people who die when they do occur but it’s offset by the volume of sudden fatal massive cardiac events in people who don’t know it’s happening.

This isn’t the only study to demonstrate the failure of aspirin to prevent heart attacks—here are a few samples:

  • American Heart Journal (2004): “The Warfarin/Aspirin Study in Heart failure (WASH) provides no evidence that aspirin is effective or safe in patients with heart failure.” (3)
  • New England Journal of Medicine (2005): “In this large, placebo-controlled, primary-prevention trial involving 39,876 initially healthy women, prophylactic aspirin at a dose of 100 mg every other day was associated with a nonsignificant reduction in the risk of major cardiovascular events, a reduced risk of total stroke and of ischemic stroke, a nonsignificant increase in the risk of hemorrhagic stroke, and no significant effect on the risk of myocardial infarction or death from cardiovascular causes…As expected, the frequency of side effects related to bleeding and ulcers was increased among women who received aspirin.” (4)
  • American Heart Journal (2011): “The current totality of evidence provides only modest support for a benefit of aspirin in patients without clinical cardiovascular disease, which is offset by its risk. For every 1,000 subjects treated with aspirin over a 5-year period, aspirin would prevent 2.9 MCE and cause 2.8 major bleeds.” (5)

Cleland’s paper goes on to say that aspirin causes bleeding in the brain and digestive system. When taken in conjunction with drugs with proven cardiovascular benefits (e.g., angiotensin converting enzyme—ACE—inhibitors), it becomes significantly more hazardous.


Aspirin Side Effects

Here are a few of the well-documented risks of taking the medication regularly:

Sounds like a lot of risk for very little reward.

What Took So Long?

The FDA has long known about the hazard of regular aspirin consumption, so why did the public just find out?

Well, Cleland’s study mentions that politics have a role in how much the public knows about the drugs they take every day:

“Meta-analysis is prone to multiple biases in favour of aspirin, including publication bias, bias due to trial and endpoint selection and bias due to interpretation. Meta-analysis should not be relied on in preference to adequately powered clinical trials. Unfortunately, the benefits of aspirin, if they exist, may be so small that a very large study indeed would be required to demonstrate that its benefits outweigh its risks.”

Since The FDA’s very public announcement, Bayer’s aspirin website now states that “Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen.”(12)