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FDA Consumer magazine
March-April 1999
Or Should You Take This Advice to Heart?
by Tamar Nordenberg
"DOES NOT AFFECT THE HEART." That assurance in the Bayer aspirin ads of the 1920s spoke to concerns of the day that some drugs could damage the life-sustaining organ. Today it's clear that aspirin can affect the heart. Ironically, it turns out the effects are beneficial, so much so that some aspirin ads now carry the American Heart Association's seal to highlight the cardiovascular effects.
In fact, of the 80 million aspirin tablets Americans take each day, most are taken not for everyday aches and pains but to reduce the risk of heart disease, according to aspirin manufacturer Bayer Corp. (See graph.)
Based on studies showing aspirin's usefulness in treating cardiovascular disease, including heart attack and stroke, the Food and Drug Administration has approved its use to treat some of these serious conditions. Most recently, last October, FDA finalized a rule to give doctors updated information about the use of aspirin for men and women who have had a heart attack or stroke or are at high risk for them.
"Used the way it should be, the information should save a lot of lives, " says Debra Bowen, M.D., deputy director of an FDA drug review office. "In addition, " she says, "the information should reduce adverse reactions and allow doctors to better target those who need to use the product. "
Beyond Pain Relief
As summarized in FDA's October rule and in the updated professional labeling for aspirin, the 100-plus-year-old drug has been shown to reduce the risk of the following medical problems:
Under the rule, the recommended doses for cardiovascular uses are lower than those doctors had been prescribing since this new use became popular: generally, 50 to 325 milligrams once daily (75 to 325 milligrams for angina and previous heart attack).
Scientists believe that aspirin's ability to reduce the body's production of hormone-like "prostaglandins" is both the reason for its effectiveness in relieving pain and reducing inflammation and its protective effects against heart attacks and strokes. Prostaglandins, it seems, can cause platelets in the blood to stick together, which can eventually lead to blocked blood vessels and prevent delivery of oxygen-rich blood to the tissues.
"When a clot forms in the brain, it can cause a stroke, and in the heart, a heart attack, " explains George Sopko, M.D., the head of the Interventional Cardiology Scientific Research Group at the National Institutes of Health. Reduce the prostaglandins, and you reduce the risk of dangerous blood clots, heart attacks, and strokes.
"Aspirin is a great drug: effective, cheap, and relatively safe, " Sopko says. "The drug has been used by just about everybody, so it may not have the sex appeal of newer drugs, but it can have a huge beneficial impact if used properly. Looking at aspirin's impact, on heart attacks for example, it may be equal to or better than some drug therapies that cost thousands of dollars." (See "Aspirin's Other Uses.")
Other pain relievers and fever-reducing drugs, such as acetaminophen, ibuprofen, naproxyn sodium, and ketoprofen, have not been shown to have aspirin's beneficial impact on cardiovascular health. "It's not the pain-relieving quality that is the major thrust of aspirin's beneficial cardiovascular effects, " Sopko explains, "but its pharmacological effect on platelets. "
Not for Everyone
Although aspirin is a familiar and readily available drug, people shouldn't take it for its cardiovascular benefits without discussing the risks of long-term use with a doctor, cautions Charles H. Hennekens, M.D., chief of preventive medicine at Brigham and Women's Hospital in Boston. "If someone feels they're a candidate, they should talk to their doctor in making the judgment if the benefits outweigh the risks. "
The same quality that gives aspirin its potential benefit--its ability to inhibit clotting of the blood--may increase the risk of excessive bleeding, including the possibility of bleeding in the brain. Some other possible risks are:
Head Start
In the wide range of patients who could see large benefits, aspirin, regrettably, is not used nearly enough, according to Hennekens. Studies bear this out, including a survey last year of elderly heart attack survivors entering nursing homes, which found that fewer than one in five were taking aspirin.
According to the American Heart Association, 5,000 to 10,000 of the 900,000 lives lost each year to cardiovascular disease could be saved if more people took aspirin upon the first signs of a heart attack. Some typical signs are an uncomfortable pressure or pain in the center of the chest (sometimes along with lightheadedness, fainting, shortness of breath, nausea, or sweating) or a pain going to the shoulders, neck and arms.
Aspirin should be used by "just about everyone" who has survived a heart attack or stroke due to a blocked blood vessel, Hennekens emphasizes, or who within the previous 24 hours has had symptoms of an evolving heart attack.
While appropriate aspirin use is important, experts say it is by no means a cure-all. "In the time crunch surrounding a heart attack, taking an aspirin provides you a head-start therapy and a better chance for a good outcome, Sopko says. "But it should never be a substitute for a physician's attention. "
And aspirin should not replace a healthy lifestyle or other helpful medical steps, FDA's Bowen says. "Physicians really need to look at aspirin in the context of complete care, as part of a whole treatment plan for people at risk of heart attack or stroke."
Tamar Nordenberg is a staff writer for FDA Consumer.
Aspirin and all other over-the-counter pain relievers and fever reducers for adults will soon carry a warning to people who drink three or more alcoholic beverages a day: Talk with your doctor before using these drugs. Heavy drinkers may have an increased risk of liver damage and stomach bleeding from these medicines, which contain aspirin, other salicylates, acetaminophen, ibuprofen, naproxen sodium, or ketoprofen.
The alcohol warning is required under an FDA rule (distinct from the aspirin labeling rule) finalized last October. Some newer over-the-counter pain relievers, including Aleve (naproxyn sodium), Orudis KT and Actron (ketoprofen), Advil Liquigels (solubilized ibuprofen), and Tylenol Extended Release (acetaminophen), have already been required to carry a warning for heavy drinkers but were not required to include the specific risks. These products, too, will need to comply with the October rule.
--T.N.
For More Information on Aspirin and the Heart
Aspirin Foundation of America
1-800-432-3247
aspirin@aspirin.org
www.aspirin.org
American Heart Association
1-800-242-8721
www.americanheart.org
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