Drug giant Bayer will spend $1
million to roll back its own claims that just about all adults
could take aspirin to prevent heart attacks, the Federal Trade
Commission (FTC) said on Tuesday.
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.
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
"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.