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 Two anti-obesity drugs, fenfluramine (brand name Pondimin) and dexfenfluramine (brand name Redux), have been withdrawn from the marketplace because of safety concerns.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

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!