FDA Says Aspirin-a-Day May Be Risky

May 07--An aspirin a day is a risky way to keep a heart attack away for people who haven't had an attack, according to a new Food and Drug Administration advisory.

The FDA statement, issued Monday, is more of a clarification than a new theory about the practice and its risks, according to two La Crosse cardiologists.

The advisory followed the agency's rejection Friday of pharmaceutical company Bayer AG's request to label and market aspirin as a preventive for heart attacks for people who do not have cardiovascular ailments.

Clinical evidence does not support "the general use of aspirin for primary prevention of a heart attack or stroke," the FDA statement said. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

The FDA reaffirmed aspirin as a secondary method of prevention for people who have had a heart attack or stroke, as well as stating that everybody should consult a physician before using the aspirin regimen.

A misconception among many is that a daily dose of aspirin -- particularly baby aspirin -- is a tried-and-true method for everybody to thin blood and avoid attack-causing clots.

"A lot of people just believe in taking things because they have heard it works from friends or relatives or in the media," said Dr. Michael Meyers, a cardiologist at Mayo Clinic Health System-Franciscan Healthcare. "They think it sounds like a good idea, so they might as well try it."

The FDA statement "looks like it's saying specifically not to make blanket recommendations for all," Meyers said. "They are distinguishing between a secondary preventive for people who have suffered heart attacks or strokes."

Dr. Paul Schoenfeld, a cardiologist at Gundersen Health System, echoed that assessment, saying, "That's a very important distinction. We don't prescribe aspirin for all comers. If you've had a heart attack or a stroke, no doubt you should be on aspirin."

But for people with a low chance for an attack "it's not worth the risk to take aspirin and have some sort of a bleeding event. It shouldn't be on a bottle saying this will prevent a heart attack," Schoenfeld said.

"It's important for everyone who hasn't had a heart attack or stroke to know their risk factors," he said.

"There are far more potent ways to modify the risk," he said, "including statins, controlling blood pressure, not smoking, getting exercise and a prudent diet."

In any case, Schoenfeld and Meyers said, patients should consult with their doctors rather than self-prescribing aspirin. A physician will evaluate the risks, including family history, and determine the best course.

"That's the art," Schoenfeld said.

Dr. Robert Temple, the FDA's deputy director for clinical science, acknowledged that several large-scale clinical studies are continuing to investigate using aspirin as a primary prevention method. The agency is monitoring the studies and will consider the evidence when they are completed, Temple said.

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