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U.S.
health officials said December 30th, 2003 they will ban the weight-loss
herb ephedra because it poses unreasonable risks such as heart attacks and
strokes.
The move marks the first
time the government has outlawed a dietary supplement
and will set a
legal precedent for action against other risky products, Health and Human
Services Secretary Tommy Thompson said.
"For too long, dietary
supplements containing (ephedra) have been heavily promoted and widely
used. They are simply too risky," Thompson said at a news conference.
The ban will take effect 60
days after publication of the new rule, which is expected in the coming
weeks. Thompson said he anticipated a legal challenge and officials were
prepared to defend the ban in court.
Makers insist ephedra, also
known as ma huang, is safe when taken as directed.
But FDA Commissioner Mark
McClellan said ephedra is a stimulant that raises blood pressure and
stresses the circulatory system, effects that have been linked to serious
heart problems, strokes and deaths. The FDA has reports of 155 deaths of
people who took ephedra and more than 16,500 complaints.
McClellan and Thompson
urged consumers to immediately stop taking ephedra products.
Ephedra
is an ingredient that is used in over-the-counter herbal medicines and
dietary supplements to promote weight loss and boost energy levels for
bodybuilding. It can cause catastrophic complications, including heart
attacks, stroke, seizures and death, researchers say.
They conclude the popular
dietary supplement, also known as ma huang and often also containing
caffeine, poses a risk that far outweighs the small benefits, if any, the
supplement offers.
Types of Ephedra
Ephedra, also known as
ephedrine, comes in several forms:
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Ephedra herb powder
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Ma huang
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Psuedoephedrine
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Epitonin
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Chinese ephedra
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Ma huang extract
The FDA does not regulate
dietary supplements and, as a result, the manufacturers of herbal
medications and dietary supplements can market these products without
prior approval or subsequent monitoring. Because of this, the incidence of
harmful or deadly side effects may be higher.
The
Food and Drug Administration is warning consumers not to purchase or
consume ephedrine-containing dietary supplements with labels that often
portray the products as apparent alternatives to illegal street drugs such
as "ecstacy," because these products pose significant health
risks to consumers. These products contain botanical, or so-called
"natural," sources of ephedrine. Ephedrine is an
amphetamine-like stimulant that can have potentially dangerous effects on
the nervous system and heart.
Side effects
Possible adverse
effects of ephedrine range from clinically significant effects such as
heart attack, stroke, seizures, psychosis and death, to clinically less
significant effects that may indicate the potential for more serious
effects (for example, dizziness, headache, gastrointestinal distress,
irregular heartbeat, and heart palpitations). Other side effects include
Insomnia, dry mouth, nervousness, general weakness, poor digestion and
irritability. If any of these symptoms develop, stop using ephedra
immediately and consult your physician. Do not take ephedra if you are
pregnant, nursing or have heart disease, anxiety disorder (panic attacks),
high blood pressure, diabetes, glaucoma, or an overactive thyroid gland
(hyperthyroidism). If you are taking any medication, consult your
physician before using this herb.
Do not take ephedra if you are taking monoamine oxidase (MAO) inhibitor
drugs, commonly prescribed for depression.
It has been linked to the deaths of at least 44 people.
The
dangers and widespread use of dietary supplements containing ephedra have
been well-documented, and include mania, psychosis, hypertension, racing
heart beat, stroke, and heart attacks. Many reported deaths have been
attributed to this herbal substance, and other adverse effects have
produced permanent disabilities. The users of products containing Ma huang
are increasing in number, owing in large part to the fact that it is an
herbal, or natural, drug and thus is perceived as being safe, and
advertised by its promoters as same. Some individuals tend to exceed the
recommended dose when they are self-medicating, and this can contribute
further to adverse effects. The molecular configuration of ephedra is
identical to that of amphetamine drugs, and probably just as expensive.
Ephedra
is found on sandy seashores and in temperate climates of both hemispheres.
The plant has stamens and pistils on separate flowers--staminate flowers
in catkins and a membraneous perianth, pistillate flowers terminal on
axillary stalks, within a two-leaved involucre. Fruit has two carpels with
a single seed in each and is a succulent cone, branches slender and erect,
small leaves, scale-like, articulated and joined at the base into a sheath.
Do not administer to
children under the age of 18 or to adults over the age of 65.
Outgoing California
governor Gray Davis, acting on a final batch of bills before leaving
office, signed legislation banning the sale of the diet supplement ephedra.
This has made California the third state, along with Illinois and New
York, to do so. This legislation, which became effective January 1,
doesn't prohibit the sale of ephedra by a pharmacist if it's actually
prescribed by a health professional for anything other than the purposes
of weight loss, body building or athletic performance enhancement.
For more information:
Weight Loss, Body Building Ephedra Can Be Deadly
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