The Food and Drug
Administration warns consumers not
to purchase or consume ephedrine (ephedra) containing dietary supplements.
Ephedrine is an amphetamine-like stimulant that can have potentially
dangerous effects on the nervous system and heart. Ephedra labels
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.
Consumers who have been injured or suffered an adverse effect
after taking a dietary supplement or any product containing an
ephedrine alkaloid should call 1-800-FDA-4010. Health professionals
who have treated patients suffering from an adverse event to these
products are urged to report the event to the FDA's MedWatch adverse
event and product problem hot line at 1-800-MEDWATCH.
The FDA is also warning of the increasing promotion of various
dietary supplement-type products as "natural" herbal
alternatives to the prescription drug combination commonly known
as "fen-phen." So-called "herbal fen-phen" products
are being marketed over the internet and through weight loss clinics,
print ads and retail outlets as natural alternatives to the prescription
drugs phentermine and fenfluramine (commonly referred to as "fen-phen").
FDA considers these products to be unapproved drugs because their
names reflect that they are intended for the same use as the anti-obesity
drugs, fenfluramine and phentermine.
The agency is warning consumers that these unapproved drugs have
not been shown to be safe or effective and may contain ingredients
that have been associated with injuries. Two anti-obesity drugs,
fenfluramine (brand name Pondimin) and dexfenfluramine (brand name
Redux), have been withdrawn from the marketplace because of safety
concerns. FDA believes the use of unapproved alternative products
may increase as a result of the withdrawal. Herbal fen-phen products
contain none of these prescription drugs.
The main ingredient of most herbal fen-phen products is ephedra,
commonly known as Ma Huang. Ephedra is an amphetamine-like compound
with potentially powerful stimulant effects on the nervous system
and heart. FDA has received and investigated more than 800 reports
of adverse events associated with the use of ephedrine alkaloid-containing
products since 1994. These events ranged from episodes of high
blood pressure, heart rate irregularities, insomnia, nervousness,
tremors and headaches to seizures, heart attacks, strokes and death.
"We will move as aggressively as the law and the science
allow us to protect the public from the potential dangers of ephedra
and other products, including taking actions to stop unlawfully
marketed drug products." Today's actions do not preclude further
measures that may be taken in response to the findings of a review
of ephedra that is currently being conducted by the Rand Corporation.
Ephedra Links
FDA
Announces Plans to Prohibit Sales of Dietary Supplements Containing
Ephedra. Consumers Advised to Stop Using Ephedra Immediately
CNN - Government announces ephedra ban The Public Citizen Health Research Group, representing 135,000
members, says the ephedra
ban comes too late.
Article by Sidney Wolfe in Science magazine: Ephedra Scientific
Evidence Versus Money/Politics
AF Surgeon General: Risks of ephedra outweigh benefits...
FDA/CFSAN Dietary Supplements: Ephedrine Alkaloids
Adverse Event Reports Associated with the Use of Dietary Supplements
Containing Ephedrine Alkaloids
Ephedra `food supplement' manufacturer, marketer and distributor
records revealed in litigation . . . The intentional adding of
dangerous drugs and controlled substances to food supplements typically
made from poorly-defined materials from unknown and unregistered
suppliers for sale to misled consumers appears to be exemplify
an insidious form of bioterrorism. (pdf
document)
Ephedra caused many poison calls
More Class Action Lawsuit Information:
Each year in Texas, and throughout the United States, millions
of people are injured through the negligence of companies that
release unsafe or defective products. If you have used or been
exposed to any of these products, we can help. There are statutes
of limitations involved in Texas class actions, so contact us as
soon as possible to protect your rights!
Jeff Rasansky is licensed to practice before all state courts
in Texas, the United States District Courts in the Northern and
Eastern Districts of Texas and the Fifth United States Circuit
Court of Appeals.
Click here to contact
The Rasansky Law Firm.
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