The FTC and U.S. Department of Justice, worried that aspirin can cause serious bleeding, hemorrhagic stroke and even death in some people, said they were worried Bayer's advertisements might encourage inappropriate use of aspirin.

Aspirin and related drugs kill about 16,500 people in the United States each year, a report published last June in the New England Journal of Medicine found.

The settlement between Bayer and the FTC must be approved by the U.S. District Court in New Jersey, where Bayer has its U.S. headquarters.

It requires the company to include the warning "Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen" in any advertisements about using the drug to prevent heart disease.

The company must also distribute a brochure warning of the risks of aspirin use.

"We wanted a national consumer education campaign that would be effective and we thought that there would have to be multiple placements over time, as well as the brochure, and when we worked out the figures it came to a million dollars," FTC spokeswoman Louise Jung said in a telephone interview.

"Full-page print ads featured in the February through May editions of major magazines will promote a toll-free number, 1-800-332-2253, for consumers to use to obtain the brochure, and more than half a million copies will be distributed through doctors' offices," the FTC said in a statement.

Aspirin clearly can prevent heart attacks and ischemic strokes — the kind caused by blood clots — in many people. In those not at risk of bleeding or stomach upset, small, daily doses, less than the size of a normal aspirin pill, have been shown to decrease the risk of a heart attack or stroke.

Giving aspirin to someone who may be having a heart attack has also been shown to reduce damage to the heart.

But doctors say the risks are large enough that no one should start taking aspirin every day without consulting a physician, and the FTC said Bayer's ads did not make this clear enough.

"We have always referred consumers to their physicians before starting an aspirin regimen. It was a dispute about how effective we were with that," a spokeswoman for Bayer's consumer division sais in a telephone interview.

"This is a win-win settlement that will greatly benefit consumers," Jodie Bernstein, director of the FTC's Bureau of Consumer Protection, said in a statement.

"This education campaign will help to clear up possible confusion about the proper use and safety of aspirin in the prevention of heart attack or stroke," Dr. Claude Lenfant, Director of the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health, added.

The Food and Drug Administration (FDA), which regulates drug use, said because aspirin is so risky, it does not allow makers to put claims about daily use on the labels of aspirin bottles.

According to the FDA, people who should not take aspirin include those who are allergic to it, those with asthma, uncontrolled high blood pressure, severe liver or kidney disease and bleeding disorders.

The FTC also said that in related cases, the Attorneys General of New York and Connecticut reached similar settlements with Bayer which call for payments of $30,000 to each state.