Ephedra Killing Dieters

[Guest guest]

We hear so much about Rezulin dangers, but Propulsid has killed at least as

many. And the death toll from Ephedra (which others in diabetes and weight

loss groups I have joined over the years heavily promoted) keeps climbing.

Here's the latest ...

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http://www.healthscout.com/cgi-bin/WebObjects/Af?ap=55 & id=93480

FDA: Ephedra Sickened or Killed 273 Users -- Disputed agency report cites

140 new cases

By Adam Marcus -- HealthSCOUT Reporter

FRIDAY, March 31 (HealthSCOUT) -- The Food and Drug Administration today

released 140 new cases of patients who fell ill, some fatally, after taking

the popular over-the-counter stimulant ephedra.

The FDA says those cases bring the number of people killed or sickened by

ephedra to 273. While the agency wouldn't verify how many people died as a

result of taking the herbal stimulant, used chiefly to promote weight loss,

earlier reports put the number at about 30. A source familiar with the

latest cases, who asked not to be identified, says they include an

additional 10 deaths.

The agency also is seeking public comments on the case reports, which must

be returned within 45 days, and plans to hold a meeting on ephedra in the

coming months.

The FDA has already tried once to bring ephedra under its regulatory

control. In June 1997, the agency proposed a rule that would limit the

amount of ephedra that could be added to dietary supplements. It also sought

warning labels on the products cautioning against taking them for more than

a week. At the time, the FDA submitted 133 cases of people who, it said, had

been harmed by ephedra.

But the General Accounting Office last August said the FDA needed more

evidence that the herbal therapy was dangerous. That report prompted today's

action.

Ephedra, derived from an Asiatic shrub, contains ephedrine, a stimulant that

acts on the central nervous system to relax bronchial tubes. A synthetic

form of ephedrine is used in bronchodilators and over-the-counter

medications like Sudafed and Actifed, which fall under the FDA's watch.

Industry defends ephedra

While the FDA currently has no legal authority over the product, the agency

has warned that ephedra, also known as Ma huang, Chinese Ephedra and

epitonin, can cause a number of serious side effects, from high blood

pressure and irregular heartbeat to nerve damage, heart attack, stroke and

death.

But one supplement industry group defends ephedra, saying the product is

safe when used as instructed on its warning labels.

Hathcock, vice president for nutritional and regulatory science at the

Council for Responsible Nutrition in Washington, D.C., says his group

reviewed the initial case reports of adverse events and could find no solid

evidence linking ephedra to the episodes.

" I don't believe there is a clear, causal relationship here, " says Hathcock,

a former FDA official who left the agency in 1995.

Even if the supplement could be definitively tied to complications, however,

Hathcock says the number of side effects -- many of them mild -- is " a very

low adverse event rate " when compared to the millions of people who are

believed to have used the product. An industry survey is now trying to learn

how much ephedra is sold in the United States each year.

The supplement group also accuses the FDA of using shoddy science in

compiling its adverse events. The agency relies on incomplete, unverified

reports, many of which are likely specious. " They simply accumulate all the

reports and the reports are not sent through any professional screening, "

Hathcock says.

Dietary supplements like ephedra fall under the blanket of the Dietary

Supplement Health and Education Act of 1994, which forbids the FDA from

regulating the products. However, the agency occasionally issues warnings

about supplements it considers dangerous.

A number of consumer and health groups have criticized the 1994 act, saying

it gives dietary supplements an unwarranted pass on necessary regulation.