FDA Bans Drugs Containing Ephedra Due to Health Risks
Ephedra is a naturally occurring substance derived from the
Asian supplement Ma Huang and is also known as Ephedrine,
Pseudoephedrine, and Epitonin. Its principal active
ingredient is Ephedrine, a drug that is regulated by the
Food and Drug Administration (FDA) and found in
over-the-counter asthma medications.
While products containing natural Ephedrine alkaloids have
long been used to treat certain respiratory symptoms in
traditional Chinese medicine, in recent years Ephedra has
been extensively promoted as a stimulant that aids in
weight loss, enhanced athletic performance and an increase
in energy levels. Ephedra is now a household name and is
primarily found in various over the counter diet pills.
Originally, the FDA could not regulate the production and
distribution of Ephedra because it is a dietary supplement
protected under the Dietary Supplement Health and Education
Act of 1994 (DSHE). According to the FDA, under this Act,
the manufacturer of the dietary supplement is responsible
for ensuring that it is safe before it is marketed to the
public.
The FDA is responsible for taking action against any unsafe
dietary supplement product after it reaches the market. As
such, most manufacturers are not required to register their
products with the FDA, nor must they get FDA approval,
before producing or selling dietary supplements.
The burden of proof lies on the shoulders of the
manufacturers, and they are required to make sure that
product label information is truthful and not misleading.
Despite the limitations the DSHE Act imposed upon the FDA
to act as an agent of change, the FDA issued numerous
warnings beginning in the early 1990's detailing the health
risks to consumers of products containing Ephedra.
Since the FDA was not able to regulate ephedra effectively
until after millions of Americans had already consumed the
stimulant, many consumers are unaware that suppliers of
products containing the drug were able to make health and
weight loss claims about these substances without a
scientific basis. These suppliers also neglected to
disclose the harmful and potentially deadly side effects of
the products.
In 1994, the FDA began receiving many reports regarding the
side effects of products containing Ephedra. While
Ephedra-containing products account for less than one
percent of all dietary supplement sales, the drug accounts
for an alarming 64 percent of adverse events associated
with dietary supplements.
Between 1994 - 2002, the FDA received more than 800 reports
of adverse effects from Ephedra and Ephedrine alkaloids.
These included but are not limited to:
* High blood pressure.
* Heart rate irregularities.
* Insomnia, nervousness.
* Tremors.
* Seizures.
* Heart attacks.
* Strokes.
* Brain hemorrhages.
* Death.
Ephedra's effects are similar to that of adrenaline and it
affects the central nervous system. Ephedra acts as a
stimulant and it can cause rapid or irregular heartbeats,
chest pain, psychosis and tremors.
Ephedra dilates the bronchial muscles, contracts nasal
mucosa, raises blood pressure, and is a cardiac stimulant.
Complications from these adverse effects can result in
strokes or heart irregularities that can cause cardiac
arrest or death. New medical research has suggested that
ephedra can also cause primary pulmonary hypertension, a
disabling and fatal condition of the lung.
Reports of these adverse side effects have increased in
recent years and include the deaths of a few high profile
athletes.
Ephedra is a dangerous and potentially life threatening
drug. As such it has become critical to monitor its
production, distribution and use. Perhaps this is why, in
2003 the states of California, Illinois and New York
individually took action and banned the use of ephedra
products. This in turn encouraged the Federal Government to
move more quickly towards a blanket ban on the stimulant.
In December 2003, the Department of Health and Human
Services (DHHS) and the FDA announced the intention to ban
Ephedra.
The DHHS stated that Ephedra can be linked to numerous
health dangers and the FDA then urged consumers to
immediately stop consuming products containing the drug.
The FDA also strongly encouraged manufacturers to recall
products still on the shelves.
Effective April 12, 2004, the FDA banned the sale of all
Ephedrine over the counter dietary supplements, having
concluded,"the totality of the available data showed little
evidence of Ephedra's effectiveness except for modest,
short-term weight loss without any clear health benefit,
while confirming that the substance raises blood pressure
and otherwise stresses the circulatory system. These
effects are linked to significant adverse health outcomes,
including heart attack and stroke."
It is now against the law to purchae or sell all dietary
products containing Ephedra. The FDA notified 62 companies
that market products containing Ephedra of the ban. Prior
to the FDA ban one of the most popular supplements
containing Ephedra was Metabolife356, which was
manufactured by Metabolife International, Inc.
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