Aspirin: A New Look at an Old Drug : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Because of its risks, aspirin is not approved for decreasing the risk of heart attack in healthy individuals. Even Hennekens isn't ready to recommend an aspirin a day for everyone, although he headed up the celebrated 1988 "Physicians' Health Study," which showed aspirin's protective effects in healthy people.

Why can't this so-called "wonder drug" help everyone? Hennekens' example: A 30-year-old woman's risk of a heart attack is typically "very small," even over the next 30 years. "It would be unfortunate if such a young woman was taking aspirin," he explains, "because it would give no benefit and could cause gastrointestinal effects or dangerous bleeding."

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 1998 survey 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."

Aspirin's Other Uses

Aspirin is sometimes used to treat rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, and some other rheumatological diseases. Aspirin labeling was updated in 1998, and now provides information on specific dosing, side effects, and toxicity of aspirin for these conditions.

More potential medical uses for aspirin are still under study — everything from treating migraines and colon, ovarian and breast cancer to improving brain function. Could an aspirin a day help you retain your memory as you age by preventing clogging of the arteries in the brain? It remains to be proven, but early studies suggest it's possible.

Three Drinks = No Pain Relievers

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), which was finalized in 1998 and gives manufacturers some time to make the label changes. 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 1998 rule.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.