FDA questioned the use of aspirin to prevent first heart attack


Editors:

Elham Reshid and Hailemariam Shimelis

Aspirin is a salicylate and non-steroidal anti-inflammatory drug (NSAID) which works by reducing substances in the body that cause pain, fever, and inflammation. Given that aspirin inhibits the function of platelets for prolonged periods, it is also used for reducing the risk of stroke and heart attack.

Since the 1990s, clinical data have shown that in people who have experienced a heart attack or, stroke or who have a disease of blood vessels in the heart, a daily low dose of aspirin can help to prevent recurrence. The American Heart Association also recommends that “people at high risk of heart attack should take a daily low dose of aspirin if told to do so by their health-care provider.

A low-dose tablet contains 80 milligrams (mg) of aspirin, compared with 325 mg in a regular strength tablet.However, consumers and patients who do not suffer from cardiovascular disease sometimes consider taking aspirin to reduce the possibility of having a heart attack or stroke, according to the FDA report and this was defined as primary prevention. Such aspirin therapy reduces the clumping action of the blood’s clotting cells, called platelets, and may prevent a heart attack, according to experts. However, experts also warn that there may be serious side effects from daily use of aspirin, including internal bleeding.

Along with this, FDA recently denied a request submitted by Bayer HealthCare, LLC, requesting a change in the prescribing information for health care professionals (professional labeling) for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease. 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 in situations where the benefit of aspirin for primary prevention has not been established and this included increased risk of bleeding in the stomach and brain.

Nevertheless, the available evidence supports the use of aspirin for preventing another heart attack or stroke in patients who have already had a heart attack or stroke, or has other evidence of coronary artery disease. In patients who have had such cardiovascular events, the known benefit of aspirin for secondary prevention outweighs the risk of bleeding.

Now, FDA has already questioned the value of taking aspirin to try to ward off a first heart attack or stroke and is currently awaiting results of additional clinical trials that are underway and are expected 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.

click for pdf here.

References:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm 

http://www.foxnews.com/health/2014/05/05/fda-questions-use-aspirin-to-prevent-first-heart-attack/ 

http://www.webmd.com/heart-disease/news/20140506/daily-aspirin-regimen-not-safe-for-everyone-fda-warns 

http://www.medicinenet.com/aspirin-oral/page2.htm

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