FDA Tells Bayer to Stop Illegal Marketing of Aspirin
Brands for Pain, Heart, Osteoporosis
Action involves Bayer Aspirin with Heart Advantage
and Bayer Womens Low Dose Aspirin + Calcium
Oct. 29, 2008 - The Food and Drug Administration
yesterday sent Warning Letters to Bayer HealthCare concerning two
unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low
Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart
Advantage (Bayer Heart Advantage). Both are potentially popular with
senior citizens because the marketing claims they are for use as pain
relievers, reducing the risks of heart disease and, Bayer Women's, for
"fighting" osteoporosis.
The products, which contain aspirin with either
phytosterols or calcium, are unapproved new drugs that require an
approved new drug application in order to be legally marketed. In
addition to being labeled.
Neither product has been approved by the FDA for
such uses. These drug uses require a health care professional's
diagnosis and supervision, and therefore these products cannot be
labeled for use by consumers and sold over-the-counter (OTC).
"The FDA considers these products new drugs and
thus they must undergo the FDA's drug approval process," said Mike
Chappell, the FDA's acting associate commissioner for regulatory
affairs. "The FDA will take enforcement action against manufacturers
found to be violating the law or attempting to circumvent the drug
approval process."
The products are labeled as being a combination of
a drug and a dietary supplement, but when a drug and a dietary
supplement are combined in a single tablet, the product is regulated by
FDA as a drug.
● Bayer Heart Advantage combines aspirin and
phytosterols in a single tablet.
● Bayer Women's combines aspirin and calcium
carbonate in a single tablet.
According to the labeling, the phytosterols in
Bayer Heart Advantage are intended to lower blood cholesterol and the
calcium in Bayer Women's is intended to strengthen bones to fight
osteoporosis.
Although certain calcium-containing dietary
supplements may bear claims to reduce the risk of osteoporosis, products
that are labeled to "fight" or otherwise treat osteoporosis are drugs
that require FDA approval.
Similarly, although certain phytosterol-containing
dietary supplements may bear claims to reduce the risk of coronary heart
disease, and may note that the mechanism by which phytosterols achieve
this effect is through lowering blood cholesterol, direct claims to
lower cholesterol are claims to prevent or treat coronary heart disease
and hypercholesterolemia, which is also a disease.
Products bearing such claims require an approved
new drug application from FDA in order to be legally marketed, and
cannot be legally marketed for OTC use.
Under its OTC drug monograph system, FDA allows
some drugs to be marketed without first obtaining agency approval. These
drugs must comply with applicable monographs, that is, regulations that
set requirements for the drugs' labeling and formulation, as well as the
indications (uses) for which the drugs can be marketed.
OTC drugs that do not meet these requirements and
that lack FDA approval are considered illegal, unapproved drugs. Bayer
Heart Advantage and Bayer Women's do not meet the conditions in any
applicable OTC monograph, and do not have FDA approval. Therefore, Bayer
Heart Advantage and Bayer Women's are unapproved new drugs.
In addition, Bayer Heart Advantage and Bayer
Women's are misbranded because their labeling lacks adequate directions
for use by consumers.
In order for a drug to have adequate directions for
use, the directions must be written so that consumers can use the
product safely for its intended purpose, without the supervision of a
health care professional. The use of these products for treatment of
heart disease and osteoporosis requires diagnosis and supervision by a
health care professional to ensure safe use.
Therefore, it is not possible, in OTC drug product
labeling, for these products to have adequate directions for their
intended uses.
The products also are misbranded because their
labeling do not have adequate warnings and are misleading. Among other
things, the labeling for the aspirin in the products includes directions
and warnings regarding short term use, but these directions and warnings
are contradicted by other directions for the phytosterols and calcium
that promote the products' daily use without any time limits.
The result is a mixed message about the products'
purposes and the length of time for which the products can be safely
used.
"The marketing of these unapproved drugs is
troubling," said Janet Woodcock, M.D., director of the FDA's Center for
Drug Evaluation and Research.
"Because OTC drugs are widely used by consumers,
without supervision by a doctor or other health care professional, the
overuse or misuse of these aspirin-containing products can put consumers
at risk for internal bleeding and other adverse events. It is essential
that companies obtain FDA approval and fully comply with FDA
regulations."
Although the FDA is not aware of significant
adverse events associated with these products, the agency is concerned
because neither product has been approved by FDA for its marketed uses.
These actions reaffirm the position taken by FDA in
two previously issued Warning Letters - one sent to B.F. Ascher & Co.,
Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni
Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain
products.
In those letters, the FDA stated that drug
ingredients combined with dietary ingredients in a single dosage form
require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA
Warning Letters risk enforcement action, such as injunctions and/or
seizure of illegal products.
For more information
Warning Letter: BAYER ASPIRIN With HEART ADVANTAGE
Warning Letter: BAYER WOMEN'S Low Dose Aspirin + CALCIUM
Questions and Answers for Consumers
FDA's Drug Safety Initiative
