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Public hearings probe ephedra safety


WASHINGTON (CNN) -- The U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition held a second day of public hearings Wednesday on ephedrine alkaloids, a substance found in many popular herbal supplements.

Also known as the Chinese herb Ma huang, ephedrine alkaloids are marketed as the dietary supplement ephedra. The stimulant is used in weight loss preparations and in supplements sold to boost energy and build muscle.

But use of products containing ephedrine alkaloids has been linked to adverse reactions including dizziness, nervousness, rapid heartbeat, and even heart attack and stroke.

"Clearly, adverse effects of ephedrine alkaloids can be serious, and indeed, fatal," said Dr. George Ricaurte of the Johns Hopkins University School of Medicine in Baltimore.

The panel heard evidence on 140 episodes of serious health consequences.

"I had respiratory failure and heart failure," said Hannah Zechzer. "When I was taken to the hospital, I was termed a 'train wreck' because there were so many things going on with me."

Zechzer had taken diet pills made with ephedra for only a week, she said.

Adverse reaction reports have ranged from the mild -- nervousness, dizziness, tremors, changes in heart rate or blood pressure, headache and stomach trouble -- to the truly dangerous, such as heart attack, hepatitis, stroke, seizures, psychosis and even death, according to FDA.

Still, ephedra and Ma huang currently are protected from FDA regulation by the Dietary Supplement Health and Education Act of 1994. And some say further regulation is unnecessary because the product is safe when taken as directed.

"There is really no correlation between the serious side effects -- I'm talking about death and stroke -- that can be attributed solely to the ephedra-containing dietary supplement," said Dr. Norbert Page, a veterinarian and toxicology expert who is spokesman for the herbal industry's Ephedra Education Council.

The hearings which began Wednesday are focusing on ephedra's safety. Possible regulatory actions will not be discussed until after the hearings have been concluded and "the available scientific information has been fully discussed," said Joseph Levitt, director of FDA's Center for Food Safety and Applied Nutrition. There is no deadline for FDA action on regulation.

Barbara Michal founded a consumer advocacy group called H.E.A.T., for Halt Ephedrine Abuse Today, after the death of her 24-year-old son.

"There are too many people who are self-medicating with these products," said Michal. "They are way too dangerous. This is nothing more than legal speed."

Ohio and Texas restrict the amount of ephedra allowed in products and its sale to those under the age of 18.

Taking herbs and prescription drugs can be dangerous, experts warn
March 20, 2000
FDA evidence too weak to restrict ephedra, report says
April 8, 1999
FDA wants warning labels for some herbal supplements
June 2, 1997

Food and Drug Administration
Halt Ephedrine Abuse Today
Ephedra Education Council
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