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For Immediate Release
Proposed FDA Alcohol Warning "Misleads
Consumer"
January 30, 1998
The Aspirin Foundation of America, Inc. (AFA) has submitted formal comments to the Food
and Drug Administration in response to a proposed alcohol warning label for aspirin and
many other drugs.
In its written comments, the Aspirin Foundation reiterates its concerns that the proposed
FDA alcohol warning for aspirin is not supported by the science and will mislead consumers.
"What is unusual about this proposal," said Dr. Thomas Bryant, president of the AFA, "is that
FDA itself has said that there is not enough evidence to show that aspirin significantly
increases the risk of gastrointestinal bleeding in heavy users of alcohol. For the agency to
agree that the scientific support is not there, yet still propose a warning is totally
unprecedented." FDA had justified its proposal in part by expressing concern that
consumers might switch from acetaminophen products like Tylenol, which have been
shown to increase the risk of liver damage when used in conjunction
with alcohol, to other pain relievers such as aspirin. "In the 25 year
history of the OTC Drug Review, never has 'switching' (from one product to another) been
used to justify a scientifically unsound warning label," Bryant noted.
The Foundation points out that the impetus for an alcohol warning on
aspirin did not originate with FDA, but originated with McNeil Consumer Products Company
as part of its strategy to minimize the marketplace effect of an alcohol warning on the sales
of Tylenol, the most popular acetaminophen OTC drug.
According to the AFA comments, McNeil then "bombarded" FDA and its Advisory
Committees with unconvincing studies and references, many funded by McNeil, to try to
convince FDA that alcohol warnings were needed on Tylenol's competitor products,
including aspirin.
FDA's own scientific review of the data provided by McNeil determined that it did not support
McNeil's claims about aspirin.
FDA's proposed warning label thus presents a danger to consumers who may perceive
aspirin and acetaminophen as presenting similar risks, the AFA said.
FDA determined that the science shows an increased risk of liver failure in heavy alcohol
users who use acetaminophen but it was unable to make the same finding about any risk of
liver damage or stomach bleeding when they use aspirin.
However, the sheer volume of studies funded by McNeil and the sensational claims about
the dangers of aspirin made by McNeil "seem to give the impression that there is some
danger there," in the words of Dr. Maria Turner, an FDA Advisory Committee member, cited
by the AFA.
The Aspirin Foundation's comments reaffirm its strong support for warnings that are
scientifically documented and clinically significant to consumers. It notes that it has fully
supported such warnings in the past, and in appropriate circumstances has assisted FDA in
developing voluntary warnings from aspirin producers at FDA's request without the
necessity of a rulemaking.
The Foundation calls on FDA to adhere to its own well established rules on warning labels,
which state that such labels should be based on evidence showing a significant risk to
consumers.
AFA is an industry organization comprised of the principal producers of aspirin and
aspirin-containing products in the United States. It was formed in 1981 to facilitate and
encourage an understanding of the health benefits of aspirin use, based on sound data and
good science.
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Contact:
Caroline Perrin
807 National Press Building, Washington, DC 20036
Phone: 800-432-3247 Fax: 202/737-8406
info@aspirin.org
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