Ephedra is a
naturally occurring substance that comes from botanicals. The
principal active ingredient ephedrine is an amphetamine-like
compound that can powerfully stimulate the nervous system and
heart. Ephedrine alkaloids are found naturally in a number of
plants, including the ephedra species (also known by the
traditional Chinese medicine name--ma huang or Chinese
Ephedra, or epitonin). In recent years, ephedra products have
been marketed as dietary supplements to promote weight loss,
increase energy, and enhance athletic performance.
The U.S. Food and Drug Administration
(FDA) advises consumers to stop using dietary supplements
containing ephedra.
In order to protect consumers, the FDA
published a final rule on April 12, 2004, that bans the sale
of dietary supplements containing ephedrine alkaloids.
After a careful review of the available
evidence about the risks and benefits of ephedra in
supplements, the FDA found that these supplements present an
unreasonable risk of illness or injury to consumers. The data
showed little evidence of ephedra's effectiveness, except for
short-term weight loss, while confirming that the substance
raises blood pressure and stresses the heart. The increased
risk of heart problems and strokes negates any benefits of
weight loss.
What evidence was
collected to determine the safety and effectiveness of ephedra
products?
The FDA reviewed information about
ephedra's pharmacology, studies of its safety and
effectiveness, newly available adverse event reports, and the
RAND Corporation report--a review of the published scientific
literature on ephedra efficacy and safety, sponsored by NCCAM
and the National Institutes of Health's Office of Dietary
Supplements. In addition, the FDA considered additional recent
studies confirming that ephedra use raises blood pressure and
otherwise stresses the circulatory system. In February 2003,
the agency solicited public comments regarding ephedra's side
effects and whether ephedra-containing dietary supplements
pose a "significant or unreasonable risk of illness or
injury."
What is covered by these actions?
Essentially all currently marketed
dietary supplements that contain a source of ephedrine
alkaloids, such as ephedra, ma huang, Sida cordifolia, and
pinellia, are affected by this rule. The rule does not pertain
to traditional Chinese herbal remedies. It generally doesn't
apply to products like herbal teas that are regulated as
conventional foods. In addition, products regulated as drugs
that contain chemically synthesized ephedrine are not dietary
supplements and not covered by this rule. These include drugs
used for the short-term treatment of asthma, bronchitis, and
allergic reactions.
Summary
There is strong evidence that ephedra
is associated with an increased risk of side effects, possibly
even fatal ones. There is no evidence that ephedra products
enhance athletic performance. There is little evidence of any
benefit except for short-term weight loss. Taken together, the
FDA recommends that consumers immediately stop using dietary
supplements containing ephedra or ephedrine alkaloids.
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