FDA: No To Aspirin To Prevent Heart Attack In Healthy
By U.S. Food and Drug Administration // May 10, 2014
LONG STANDING CLINICAL DEBATE OVER 'PRIMARY' PREVENTION OF CVD
ABOVE VIDEO: In the latest development in a long-simmering debate, News Loop Health reports that the FDA has announced that aspirin should not be marketed for the prevention of a first heart attack or stroke in people with no history of cardiovascular disease.
EDITOR’S NOTE: The U.S. Food and Drug Administration (FDA) has denied a citizen’s petition from Bayer to add “primary” prevention of heart attacks and strokes to aspirin labeling.
Although daily aspirin may be recommended for people who have already had a heart attack, according to the FDA it’s a different story for people who have never had one. The FDA’s comprehensive review of the literature related to aspirin’s benefits suggested that for people who have no history of cardiovascular disease (CVD), there’s simply not enough evidence to suggest that the benefits of aspirin outweigh its risks.
The efficacy and safety of aspirin used as a primary preventative measure for CVD has been the subject of long-standing clinical debate. The American Heart Association currently supports the use of aspirin for primary prevention when recommended by a physician in high risk patients, and aspirin for primary prevention of CVD is widely used.
The agency has gone directly to the public with a “consumer update,“ reproduced in its entirety below, warning healthy people not to expect that daily aspirin will help them avoid cardiovascular events.
The FDA will continue to track ongoing large-scale studies to see if anything should change in their recommendation. At this time, it appears that you should forego the aspirin if you’re using it to prevent a first heart attack. However, it’s imperative that you speak with your doctor to be sure, especially if you’re already taking aspirin. He or she can also discuss with you other ways – and there are many – to help prevent having a heart attack.
—Dr. Jim Palermo, Editor-in-Chief
FDA CONSUMER UPDATE–Can an aspirin a day help you ward off a heart attack or stroke?
Scientific evidence shows that taking an aspirin daily can help prevent a heart attack or stroke in some people, but not in everyone. It also can cause unwanted side effects.
According to Robert Temple, M.D., deputy director for clinical science at the Food and Drug Administration (FDA), one thing is certain: You should use daily aspirin therapy only after first talking to your health care professional, who can weigh the benefits and risks.
WHO CAN BENEFIT?
“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence,” Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as “secondary prevention.”
However, after carefully examining scientific data from major studies, the 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.
CAUTION NEEDED WITH OTHER BLOOD THINNERS
When you have a heart attack, it’s because one of the coronary arteries (which provide blood to the heart), has developed a clot that obstructs the flow of blood and oxygen to the heart. Aspirin works by interfering with your blood’s clotting action.
Care is needed when using aspirin with other blood thinners, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis).
What about people who have not had heart problems or a stroke but who, due to family history or showing other evidence of arterial disease are at increased risk? Is an aspirin a day a safe and effective strategy for them?
Again, Temple emphasizes, the clinical data do not show that a benefit in such people.
He adds, however, that there are a number of ongoing, large-scale clinical studies continuing to investigate the use of aspirin in primary prevention of heart attack or stroke. FDA is monitoring these studies and will continue to examine the evidence as it emerges.
IN THE MEANTIME
The bottom line is that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering. And if you’re thinking of using aspirin therapy, you should first talk to your health care professional to get an informed opinion, Temple says.
Finally, how much aspirin you take matters. It’s important to your health and safety that the dose you use and how often you take it is right for you. Your health care professional can tell you the dose and frequency that will provide the greatest benefit with the least side effects.
If your health care professional recommends daily aspirin to lower the risk of a heart attack and clot-related stroke, read the labels carefully to make sure you have the right product. Some drugs combine aspirin with other pain relievers or other ingredients, and should not be used for long-term aspirin therapy.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.