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Old Tue, Nov-07-00, 08:33
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tamarian tamarian is offline
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Plan: Atkins/PP/BFL
Stats: 400/223/200 Male 5 ft 11
BF:37%/17%/12%
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Location: Ottawa, ON
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Tuesday November 07 03:06 AM EST
Study: Ephedra May Have Deadly Effects
By Adam Marcus
HealthScout Reporter

MONDAY, Nov. 6 (HealthScout) -- A popular herbal weight-loss treatment appears to pose a real risk of heart attack and other serious and even deadly complications in people who use it, researchers say.

Earlier this year, the FDA said that between 1997 and 1999 it had received 140 reports of illness or death linked to ephedra alkaloids.

The compounds are stimulants derived from shrubs that are similar to the ephedrine found in over-the-counter cold remedies like Sudafed. Since then, the agency has gotten another 103 such reports, but those haven't been investigated.

To help clarify the risks of ephedra, the FDA had asked researchers at the University of California at San Francisco to evaluate the 140 cases of suspected adverse events. That analysis, which the agency received last spring, was released today by the New England Journal of Medicine, which is publishing the results early because of their potential impact on consumers.

"The benefit [of ephedra] is small or none and yet the risk is real," says Dr. Christine Haller, a UCSF toxicologist and lead author of the study. "I advise people not to take" products with the substance.

Of the 140 incidents, 31 percent were "definitely or probably" the result of ephedra, the researchers claim, accounting for five cases of cardiac arrest, four strokes and three deaths. An additional 31 percent were "possibly" tied to the compound.

Researchers call for warnings

Taken together, these two groups accounted for 10 deaths and more than a dozen cases of permanently disabling injuries. Ephedra was also implicated in high blood pressure, abnormal heart rhythms, seizures and palpitations.

The researchers say that in light of their study, products that contain ephedra should carry uniform warnings about its risks. They also call for more research into the supplement.

Ephedra is sold under a variety of names including Ma huang, Chinese Ephedra and epitonin.

In 1999, supplement makers sold an estimated 3 billion doses of the supplement, which is also used as a performance enhancement and a pick-me-up.

In June 1997, the FDA proposed a rule that would have limited the amount of ephedra that could be added to dietary supplements to 8 milligrams. It would also have put warning labels on the products cautioning against taking them for more than a week, and advising consumers not to combine them with other stimulants.

But the General Accounting Office (GAO), reviewing the matter at the request of Congress, told the agency it needed more evidence the herbal therapy was truly dangerous.

The FDA earlier this year abandoned the dose and duration parts of its proposed rule, though it has kept the warning against mixing ephedra with stimulants. The agency, which held hearings on the substance in August, plans to issue a new ruling by the end of the year, officials say.

John Hathcock, vice president for nutritional and regulatory science at the Council for Responsible Nutrition, says his group believes ephedra is both effective and safe.

Hathcock cites a new report by Harvard and Columbia University researchers showing that people who took a combination of 90 milligrams of ephedra and caffeine lost more weight -- but had no more adverse events -- than those who took dummy pills.

"I am satisfied that those results give no indication that ephedra is unsafe at those dosages," Hathcock says.

Last month, a group of supplement associations called on the FDA to issue national guidelines for ephedra products.

The group, which includes the American Herbal Products Association and the Consumer Healthcare Products Association, says supplements with ephedra should carry warning labels cautioning their use only by people over 18. Labels should also warn that individuals should have no more than 25 milligrams per serving of the substance. They should say as well that the supplements don't work better and may well be dangerous, in higher doses, according to the associations.

The proposed label also warns against mixing ephedra products with prescription drugs, as well as nonprescription drugs containing PPA, a chemical common in diet pills and cold remedies. The FDA warned consumers about PPA today, citing possible stroke risks.

FDA officials say the agency will make a decision about its plans to regulate ephedra by the end of this year.

What To Do

For the industry perspective on the compound, check out the Council for Responsible Nutrition, or the Consumer Healthcare Products Association.

Florida International University has a list of many products containing ephedra.

Read these other HealthScout articles about ephedra.



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  #2   ^
Old Tue, Nov-07-00, 08:35
tamarian's Avatar
tamarian tamarian is offline
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Posts: 19,570
 
Plan: Atkins/PP/BFL
Stats: 400/223/200 Male 5 ft 11
BF:37%/17%/12%
Progress: 89%
Location: Ottawa, ON
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And the opposing view on Ephedra:

http://www.drumlib.com/
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